이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

2018년 9월 30일 업데이트: Astellas Pharma Inc

ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects -

The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.

연구 개요

연구 유형

중재적

등록 (실제)

36

단계

  • 1단계

연락처 및 위치

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

연구 장소

    • Tokyo
      • Sumida, Tokyo, 일본
        • Site JP00001

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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
  • Body Mass Index (BMI) at screening: ≥ 17.6 kg/m^2 and < 26.4 kg/m^2 [BMI = Body weight (kg) ÷ {Body height (m)^2}].
  • Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
  • Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
  • Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.

Exclusion Criteria:

  • Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
  • Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission.
  • Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1).
  • Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
  • Any deviation from the normal range of routine 12-lead ECG at screening.
  • Subjects with a complication or history of drug allergies.
  • Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
  • Subjects with a history of gastrointestinal resection except for appendicitis.
  • Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
  • Subjects who received ASP8062 previously.
  • Subject has a relevant history of suicide attempt or suicidal behavior.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ASP8062 lower dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
실험적: ASP8062 middle dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
실험적: ASP8062 higher dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
위약 비교기: Placebo
Subjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
위약은 구두로 투여됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety assessed by incidence of adverse events
기간: Up to Day 38
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Up to Day 38
Safety assessed by vital signs: supine blood pressure
기간: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by vital signs: supine pulse rate
기간: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by vital signs: axillary body temperature
기간: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Orthostatic challenge tests
기간: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Up to Day 20
Safety assessed by laboratory tests: Hematology
기간: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Biochemistry
기간: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Urinalysis
기간: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by 12-lead electrocardiogram
기간: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Up to Day 21
Columbia-Suicide Severity Rating Scale
기간: Up to Day 20
To assess the suicide risk
Up to Day 20
Safety assessed by body weight
기간: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
Up to Day 38

2차 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time to maximum concentration (Tmax)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Terminal elimination half-life (t1/2)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
기간: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
기간: From Day 7 to Day 20
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 20
PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
기간: Up to Day 6
To assess the PK of ASP8062 in single dose part
Up to Day 6
PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time of the last measurable concentration (tlast)
기간: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
Accumulation Ratio (Rac) of Cmax
기간: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Rac of AUC
기간: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Peak-Trough Ratio for last dosing in multiple dose part
기간: Day 20 and Day 21
To assess the PK of ASP8062 in multiple dose part.
Day 20 and Day 21

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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 6월 20일

기본 완료 (실제)

2017년 10월 6일

연구 완료 (실제)

2017년 10월 6일

연구 등록 날짜

최초 제출

2017년 6월 9일

QC 기준을 충족하는 최초 제출

2017년 6월 9일

처음 게시됨 (실제)

2017년 6월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 30일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

ASP8062에 대한 임상 시험

3
구독하다