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건강한 참여자에서 GSK3494245의 안전성, 내약성 및 약동학(PK) 조사

2026년 4월 8일 업데이트: GlaxoSmithKline

건강한 참가자를 대상으로 GSK3494245 단일 용량(식후 및 절식 상태 모두)의 안전성, 내약성 및 약동학을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 인체 연구 최초

이것은 GSK3494245 단일 용량의 안전성, 내약성 및 PK를 평가하기 위한 1상, 이중 맹검, 무작위, 위약 대조, 인간 최초(FTIH) 연구입니다. 연구는 순차적인 방식으로 수행되는 3개의 코호트로 구성될 것입니다. 코호트 1 및 2는 단일 상승 용량(SAD), 교차 디자인으로 구성되며, 여기서 각 참가자는 공복 상태에서 GSK3494245의 최대 3회 상승 경구 용량과 1회 위약 용량을 받게 됩니다. 각 용량 수준에서 GSK3494245와 위약은 맹검 방식으로 무작위 배정 일정에 따라 각 기간 내에 3:1 비율로 투여됩니다. 코호트 3은 1:1 비율로 공복 후 섭식 상태 하의 1개 투약 요법 및 급식 후 공복 조건 하의 1개 요법을 포함하는 2방향 교차로 구성될 것이다. 급식 상태는 식품 투여 후 단일 용량의 GSK3494245의 안전성, 내약성 및 PK의 효과를 조사할 것입니다.

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
종료됨

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

상세 설명

The study originally planned to include 2 parts - a single ascending doses (SAD) part and a multiple ascending doses (MAD) part, incorporating a food effect component to investigate the influence of food on the PK of GSK3494245. However, only the SAD part was conducted due to a decision to terminate the study early.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (실제)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
59

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처

임상 연구를 위한 등록 질문에 답변할 수 있는 사람의 이름과 연락처 정보. 연구가 수행되는 각 위치에는 이러한 질문에 더 잘 대답할 수 있는 특정 연락처가 있을 수 있습니다.

연구 연락처 백업

연구 장소

  • 영국
      • Cambridge, 영국, CB2 2GG
        • GSK Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

설명

포함 기준

  • 참가자는 정보에 입각한 동의서에 서명할 당시 18세 이상 50세 미만이어야 합니다.
  • 참가자는 병력, 신체 검사, 실험실 테스트 및 심장 모니터링을 포함한 의료 평가를 기반으로 조사자 또는 의학적으로 자격을 갖춘 피지명인이 결정한 바와 같이 건강해야 합니다. 포함 또는 제외 기준에 구체적으로 나열되지 않은 임상적 이상 또는 실험실 매개변수가 있는 참가자는 조사자가 의료 모니터(Medical Monitor)와 협의하는 경우에만 포함될 수 있습니다. 필요한 경우) 결과가 추가 위험 요소를 도입할 가능성이 없으며 연구 절차를 방해하지 않는다는 데 동의하고 문서화합니다.
  • 체중 >=50 킬로그램(kg) 및 18.5-28 평방미터당 킬로그램(kg/m^2) 범위 내의 체질량 지수(BMI)(포함).
  • 남성 참가자만 가능합니다. 가임 여성 파트너가 있는 남성 참여자는 중재 기간 동안과 연구 치료의 마지막 투여 후 최소 90일 동안 피임법을 사용하고 이 기간 동안 정자 기증을 삼가는 데 동의해야 합니다.
  • 정보에 입각한 동의 양식(ICF) 및 프로토콜에 나열된 요구 사항 및 제한 사항을 준수하는 것을 포함하는 서명된 정보에 입각한 동의를 제공할 수 있습니다.

제외 기준

  • 약물의 흡수, 대사 또는 배설을 현저하게 변화시킬 수 있는 심혈관, 호흡기, 간, 신장, 위장, 내분비, 혈액 또는 신경 장애의 병력 또는 존재; 연구 치료제를 복용할 때 위험을 구성하는 것; 또는 데이터 해석을 방해합니다.
  • 조사자가 결정한 비정상적인 혈압.
  • 리슈만편모충증의 이전 병력.
  • ALT(Alanine aminotransferase)가 정상 상한치(ULN)의 1.5배를 초과합니다.
  • ULN의 1.5배를 초과하는 총 빌리루빈(총 빌리루빈을 분할하고 직접 빌리루빈이 35%[%] 미만인 경우 ULN의 1.5배를 초과하는 고립 빌리루빈이 허용됨).
  • 간 질환 또는 알려진 간 또는 담도 이상(길버트 증후군 또는 무증상 담석 제외)의 현재 또는 만성 병력.
  • 임상적으로 중요한 위염 또는 위십이지장 궤양의 현재 또는 병력 또는 비스테로이드성 항염증제(NSAID)의 정기적인 사용.
  • 주당 14단위 이상의 알코올 소비(남성 지원자).
  • 조사자의 임상적 판단에 기초한 타당한 임상적 설명 없이 미각 또는 후각 변화의 현재 또는 과거력.
  • 3중 심전도의 평균을 기준으로 QTc가 450밀리초(msec)를 초과합니다.
  • 조기 심실 수축(PVC) 삼중체 및 24시간 내 500개 이상의 단일 PVC를 포함한 파형 이상 또는 조사자의 재량에 따른 기타 이상.
  • 심장 부정맥 또는 심장 질환의 병력 또는 긴 QT 증후군의 가족 또는 개인 병력.
  • 약초 약물, NSAID, 양성자 펌프 억제제(PPI) 또는 항히스타민 2 수용체(H2) 길항제를 포함한 일반의약품 또는 처방약의 과거 또는 의도된 사용이 7일(또는 약물이 잠재적인 효소인 경우 14일) 유도제) 또는 투여 전 5 반감기(둘 중 가장 긴 것). 기타 병용 약물은 의료 모니터와 상의하여 조사자가 사례별로 고려할 수 있습니다. 파라세타몰이 허용됩니다(<=2g/일로 제한).
  • 56일 기간 내에 500밀리리터(mL)를 초과하는 혈액 또는 혈액 제품의 손실을 초래하는 연구 참여.
  • 첫 투여일 이전 12개월 이내에 4개 이상의 새로운 화학 물질에 노출.
  • 조사 연구 중재 또는 기타 유형의 의학 연구와 관련된 다른 임상 연구에 동의하기 전 지난 30일 이내에 현재 등록 또는 과거 참여.
  • 이 임상 연구에 대한 현재 등록 또는 과거 참여.
  • 연령에 적합한 사구체 여과율(GFR) <90(1.73m 제곱당 분당 밀리리터[mL/min/1.73m^2])인 만성 신장 질환 역학 협력(CKD-EPI)으로 정의된 신장 기능이 있는 참가자.
  • 소변 알부민 스크리닝:크레아티닌 비율 >30mg/g(밀리몰당 >3mg/mmol)
  • 스크리닝 시 B형 간염 표면 항원(HBsAg) 검사 결과의 존재.
  • 스크리닝 시 양성 C형 간염 항체 검사 결과.
  • 스크리닝 시 양성 C형 간염 리보핵산(RNA) 검사 결과.
  • 인간 면역결핍 바이러스(HIV) 항체 검사 양성.
  • 임상적으로 유의한 혈뇨 및/또는 단백뇨의 존재.
  • 흡연 또는 스크리닝 전 3개월 이내에 담배 또는 니코틴 함유 제품의 정기적인 사용 또는 이력을 나타내는 일산화탄소 수준.
  • 양성 사전 연구 약물/알코올 스크린.
  • 알려진 남용 약물의 정기적인 사용.
  • 식품 효과 코호트 3에만 해당: 참가자는 식이 제한(예: 유당 불내성)이 없거나 젤라틴 또는 적응된 표준 식사(지방 함량 35-40% 포함)를 먹을 수 없어야 합니다.
  • 식품 효과 코호트 3만: 담낭 수술 또는 담낭 제거의 병력 또는 급성 질환 상태의 병력(예: 담석증) 연구 치료를 받기 전 14일 이내에
  • 참가자는 스크리닝 전 6개월 동안 리슈만편모충/기생충 감염의 유병률이 높은 지역(조사관이 결정한 대로)을 여행한 적이 없거나 연구 치료의 최종 투여 후 3개월 동안 여행할 의도가 없어야 합니다.
  • 조사자 또는 GSK Medical Monitor의 의견에 따라 연구 참여를 금하는 임의의 연구 치료제 또는 그 구성요소 또는 약물 또는 기타 알레르기에 대한 민감성.
  • 코로나 바이러스 질병 2019(COVID-19) 감염에 대한 긍정적인 실험실 확인 또는 COVID-19에 대한 높은 임상 의심 지수.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: Cohort 1 Treatment Sequence (Seq) 1: GSK3494245 20 milligram (mg) fasted/Placebo (PBO)
Participants received 20 mg of GSK3494245 during dosing period 1 and Placebo matching the active dose amount during dosing period 2 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 1 Treatment Seq 2: PBO/GSK3494245 40mg fasted
Participants received Placebo during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 1 Treatment Seq 3: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 1 Treatment Seq 4: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 2 Treatment Seq 1:GSK3494245 40mg fasted/GSK3494245 80mg fasted/GSK3494245 120mg fasted/PBO
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and matching Placebo during dosing period 4 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 2 Treatment Seq 2:GSK3494245 40mg fasted/GSK3494245 80mg fasted/PBO/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, matching placebo during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 2 Treatment Seq 3:GSK3494245 40mg fasted/PBO/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, matching placebo during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 2 Treatment Seq 4: PBO/GSK3494245 80mg fasted/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received placebo during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 2A Treatment Seq 1: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 2A Treatment Seq 2: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 2A Treatment Seq 3: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 2A Treatment Seq 4: PBO fasted
Participants received Placebo during dosing period 1 under fasted conditions, at Day 1.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3 Treatment Seq 1: PBO fed/PBO fasted/GSK3494245 80mg fasted/GSK3494245 80mg fed
Participants received Placebo in fed conditions during dosing period 1, Placebo in fasted conditions during dosing period 2, 80 mg of GSK3494245 in fasted conditions during dosing period 3 and 80 mg of GSK3494245 in fed conditions during dosing period 4.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3 Treatment Seq 2: PBO fasted/GSK3494245 80mg fed/PBO fed/GSK3494245 80mg fasted
Participants received Placebo in fasted conditions during dosing period 1, 80 mg of GSK3494245 in fed conditions during dosing period 2, placebo in fed conditions during dosing period 3 and 80 mg of GSK3494245 in fasted conditions during dosing period 4.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3 Treatment Seq 3: GSK3494245 80mg fed/GSK3494245 80mg fasted/PBO fasted/PBO fed
Participants received 80 mg of GSK3494245 in fed conditions during dosing period 1, 80 mg of GSK3494245 in fasted conditions during dosing period 2, Placebo in fasted conditions during dosing period 3 and placebo in fed conditions during dosing period 4.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3 Treatment Seq 4: GSK3494245 80mg fasted/PBO fed/GSK3494245 80mg fed/PBO fasted
Participants received 80 mg of GSK3494245 in fasted conditions during dosing period 1, Placebo in fed conditions during dosing period 2, 80 mg of GSK3494245 in fed conditions during dosing period 3 and placebo in fasted conditions during dosing period 4.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3A Treatment Seq 1: PBO fed/GSK3494245 240mg fed
Participants received placebo in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3A Treatment Seq 2: GSK3494245 160mg fed/PBO fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and Placebo in fed conditions during dosing period 2.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
의약품: Placebo
Matching placebo capsules were provided
실험적: Cohort 3A Treatment Seq 3: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
실험적: Cohort 3A Treatment Seq 4: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
의약품: GSK3494245
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Number of Participants With Adverse Events (AEs)
기간: From Day 1 (first dose) up to 14 days post last dose in each treatment period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
From Day 1 (first dose) up to 14 days post last dose in each treatment period
Number of Participants With Serious Adverse Events (SAEs)
기간: From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
기간: From Day 1 (first dose) up to 2 days post last dose in each treatment period

A TEAE and treatment emergent SAE is considered any untoward medical occurrence in a clinical study participant, considered by the investigator to have a causal relationship with study treatment.

A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
From Day 1 (first dose) up to 2 days post last dose in each treatment period
Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: basophils, neutrophils, eosinophils, lymphocytes, monocytes and platelets. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. Standard deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular volume. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular hemoglobin. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: erythrocytes and reticulocytes. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Hemoglobin
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: hemoglobin. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Hematocrit and Reticulocytes
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the hematology parameters: hematocrit and reticulocytes. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT)
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the clinical chemistry parameters: ALT, ALP, AST, CPK, and GGT. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Albumin, Protein
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the clinical chemistry parameters: albumin and protein. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Calcium Corrected for Albumin, Glucose, Lactic Acid, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, and Urea
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for clinical chemistry parameters: bicarbonate, calcium corrected for albumin, glucose, lactic acid, magnesium, phosphate, potassium, sodium, triglycerides, urea. Baseline was defined as the last non-missing pre-dose assessment for each cohort. Generally, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments on Day 1 lacked timing, the first recorded was used. If one Day 1 assessment lacked timing, the last available from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, Baseline was set to missing. Change from baseline is defined as post-dose value minus baseline value. SD=0.0000 indicates SD below the detectable assay limit, approximated to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the clinical chemistry parameters: bilirubin, creatinine, direct bilirubin. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: C-reactive Protein (CRP)
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the clinical chemistry parameters: CRP. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: pH
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Blood samples were collected for the assessment of the clinical chemistry parameters: pH. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 2 and Day 4 in each treatment period compared to Baseline
Number of Participants With Worst-case Urinalysis Results
기간: From Day 1 up to 14 Days post last dose
Urine samples were collected for the assessment of urinalysis parameters, which include pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
From Day 1 up to 14 Days post last dose
Summary of Change From Baseline in Physical Examinations: Body Mass Index (BMI)
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Vital Signs: Respiratory Rate
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Supine Diastolic Blood Pressure, Supine Systolic Blood Pressure
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Supine Pulse Rate
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Tympanic Membrane Temperature
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Physical Examinations: Weight
기간: At Day 2 and Day 4 in each treatment period compared to Baseline
Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT (QTc) Interval, QT Interval Corrected Using Bazett's Formula, QT Interval Corrected, Using Fridericia's Formula
기간: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured the PR interval, QRS interval, QT interval, and QTc interval. Baseline was defined as the last non-missing pre-dose assessment for each cohort. In general, assessments on Study Day 1 taken before the first dose were used as Baseline. If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used. If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used. If no Day 1 assessments were available, the most recent data from Day -1 or screening was used. If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing. Change from baseline value is defined as post-dose value minus baseline value.
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Number of Participants With Abnormal Cardiac Telemetry Findings
기간: Up to 24 hours post first dose on Day 1
Telemetry is defined as the continuous monitoring of a participant's heart rate and rhythm from a remote location.
Up to 24 hours post first dose on Day 1

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve (AUC[0-t]) of GSK3494245 Following Single Dose Administration, Under Fasting Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC (0-t) of GSK3494245 Following Single Dose Administration Under Fed Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC-time Curve From Time Zero to Extrapolated to Infinity (AUC[0-inf]) of GSK3494245 Following Single Dose Administration Under Fasting Condition
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC (0-inf) of GSK3494245 Following Single Dose Administration Under Fed Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Maximum Observed Plasma Drug Concentration (Cmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Cmax is defined as the maximum concentration of the drug in plasma.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Cmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Cmax is defined as the maximum concentration of the drug in plasma.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Tmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Apparent Terminal Half-life (t1/2) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
t1/2 of GSK3494245 Following Single Dose Administration Under Fed Conditions
기간: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
Dose-proportionality Assessment Using AUC(0-inf) Following a Single Dose of GSK3494245
기간: At Day 1 (post-dose)
A power model was used to assess the dose proportionality. A slope of 1 indicates that PK increased linearly with the dose. A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
At Day 1 (post-dose)
Dose-proportionality Assessment Using Cmax Following Single Dose of GSK3494245
기간: At Day 1 (post-dose)
A power model was used to assess the dose proportionality. A slope of 1 indicates that PK increased linearly with the dose. A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
At Day 1 (post-dose)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
GlaxoSmithKline

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 연구 책임자: GSK Clinical Trials, GlaxoSmithKline

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2020년 9월 29일

기본 완료 (실제)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 1월 14일

연구 완료 (실제)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 1월 14일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2020년 8월 5일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2020년 8월 5일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2020년 8월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 5월 1일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 4월 8일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • 208441
  • 2019-004492-39 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

이 연구에 대한 IPD는 임상 연구 데이터 요청 사이트를 통해 제공됩니다.

IPD 공유 기간

IPD는 연구의 1차 종점, 주요 2차 종점 및 안전성 데이터의 결과를 발표한 후 6개월 이내에 제공될 예정입니다.

IPD 공유 액세스 기준

액세스는 연구 제안서가 제출되고 독립 검토 패널의 승인을 받은 후 데이터 공유 계약이 체결된 후에 제공됩니다. 액세스는 초기 12개월 동안 제공되지만 정당한 경우 최대 12개월까지 연장할 수 있습니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

당사는 당사 웹 사이트에서 최상의 경험을 제공하기 위해 쿠키를 사용합니다. 자세한 내용은 개인 정보 보호 및 쿠키 정책 을주의 깊게 읽어보십시오. ...>>>귀하는 정책에 설명 된대로 귀하의 웹 사이트 또는 컴퓨터에서 쿠키를 삭제하여 언제든지 귀하의 기본 설정을 변경하거나 동의를 철회 할 수 있습니다. 동의하고 아래 "설정 관리"섹션에서 해당 상자를 선택하여 기본 설정을 선택하십시오. 이 웹 사이트의 일부를 사용하기 전에 서비스 약관 을주의 깊게 읽어 보시기 바랍니다.
«설정 관리