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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

2019년 1월 22일 업데이트: Janssen Research & Development, LLC

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

86

단계

  • 1단계

연락처 및 위치

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

연구 장소

  • 벨기에
      • Antwerpen, 벨기에, 2060
        • SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

참여기준

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

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
  • Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
  • Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
  • A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2

Exclusion Criteria:

  • History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
  • History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
  • Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
  • Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)
Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
의약품: JNJ-64991524 Dose Level 1
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
실험적: Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 2
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
실험적: Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 3
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
실험적: Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)
Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 4
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
실험적: Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 5
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
실험적: Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
실험적: Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 7
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
실험적: Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 8
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
실험적: Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 9
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
실험적: Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1.
의약품: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
의약품: JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
기간: Up to Day 20
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
Up to Day 20
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
기간: Up to Day 28
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Up to Day 28
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
기간: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

2차 결과 측정

결과 측정
측정값 설명
기간
Plasma Concentration of JNJ-64991524
기간: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

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)

2017년 11월 15일

기본 완료 (실제)

2018년 11월 20일

연구 완료 (실제)

2018년 11월 20일

연구 등록 날짜

최초 제출

2017년 11월 15일

QC 기준을 충족하는 최초 제출

2017년 11월 15일

처음 게시됨 (실제)

2017년 11월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 22일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CR108376
  • 2017-000229-11 (EudraCT 번호)
  • 64991524EDI1001 (기타 식별자: Janssen Research & Development, LLC)

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. .

JNJ-64991524 Dose Level 1에 대한 임상 시험

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