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Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants

2018년 3월 28일 업데이트: Janssen Research & Development, LLC

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects

The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).

연구 개요

연구 유형

중재적

등록 (실제)

40

단계

  • 1단계

연락처 및 위치

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

연구 장소

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

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
  • Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included and a body weight not less than 50.0 kilogram (kg)
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
  • Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
  • Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later

Exclusion Criteria:

  • Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic or metabolic disturbances
  • Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative [for example, sibling, offspring, or biological parent])
  • Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
  • Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients

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: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
일치하는 위약이 투여됩니다.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
실험적: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
일치하는 위약이 투여됩니다.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
실험적: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
일치하는 위약이 투여됩니다.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
실험적: Panel 2: Treatment D
Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1. Each treatment period will be separated by a washout period of 7 days.
일치하는 위약이 투여됩니다.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
실험적: Panel 2: Treatment E
Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
일치하는 위약이 투여됩니다.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
실험적: Panel 2: Treatment F
Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3. Each treatment period will be separated by a washout period of 7 days.
일치하는 위약이 투여됩니다.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
기간: From Day 1 to Day 14 after intake of ODV
The Cmax is the maximum observed analyte concentration.
From Day 1 to Day 14 after intake of ODV
Time to Reach Maximum Observed Concentration (Tmax) of ODV
기간: From Day 1 to Day 14 after intake of ODV
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
From Day 1 to Day 14 after intake of ODV
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
기간: From Day 1 to Day 50-55 after intake of ODV
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
From Day 1 to Day 50-55 after intake of ODV
Elimination Rate Constant (Lambda[z]) of ODV
기간: From Day 1 to Day 50-55 after intake of ODV
Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
From Day 1 to Day 50-55 after intake of ODV
Elimination Half-Life (t1/2) of ODV
기간: From Day 1 to Day 50-55 after intake of ODV
Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
From Day 1 to Day 50-55 after intake of ODV
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
기간: From Day 1 to Day 50-55 after intake of ODV
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
From Day 1 to Day 50-55 after intake of ODV
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
기간: Up to 50-55 days after intake of ODV
Up to 50-55 days after intake of ODV
Maximum Observed Concentration (Cmax) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
The Cmax is the maximum observed analyte concentration.
From Day 1 to Day 4 after intake of AL-335
Time to Reach Maximum Observed Concentration (Tmax) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
The Tmax is defined as actual sampling time to reach maximum observed concentration.
From Day 1 to Day 4 after intake of AL-335
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
From Day 1 to Day 4 after intake of AL-335
Elimination Rate Constant (Lambda[z]) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
From Day 1 to Day 4 after intake of AL-335
Elimination Half-Life (t1/2) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
From Day 1 to Day 4 after intake of AL-335
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
기간: From Day 1 to Day 4 after intake of AL-335
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
From Day 1 to Day 4 after intake of AL-335
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
기간: Up to 30 to 35 days after last intake of AL-335
Up to 30 to 35 days after last intake of AL-335

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, 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)

2016년 6월 14일

기본 완료 (실제)

2016년 9월 9일

연구 완료 (실제)

2016년 9월 30일

연구 등록 날짜

최초 제출

2016년 6월 10일

QC 기준을 충족하는 최초 제출

2016년 6월 29일

처음 게시됨 (추정)

2016년 7월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 28일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CR108178
  • 64294178HPC1005 (기타 식별자: Janssen Research & Development, LLC)
  • 2015-005639-42 (EudraCT 번호)

약물 및 장치 정보, 연구 문서

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아니

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위약에 대한 임상 시험

3
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