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A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

2013년 6월 24일 업데이트: Janssen R&D Ireland

A Phase I, Open-Label, Randomized, 3-Panel, 3-way Crossover Trial in Healthy Adult Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of 2 Liquid Formulations or 2 Different Capsule Concept Formulations Compared ot the Phase III 150 mg Capsule, and to Assess the Effect of Food on the Bioavailability of TMC435 Following Administration of the Liquid Formulations.

The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

TMC435 is being investigated for the treatment of chronic hepatitis C infection. The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule. Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule. The study will be performed in healthy adult participants and is divided over 3 panels. Participants will be randomized within a panel. Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design. In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III. In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III. In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect. In all treatments, the participants will receive medication on Day 1 of each treatment. There will be a washout period of at least 7 days between subsequent treatments. The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.

연구 유형

중재적

등록 (실제)

72

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

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening.
  • Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.

Exclusion Criteria:

  • All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
  • Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
  • Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements.
  • History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
  • Participation in an investigational drug trial with TMC435.
  • Infected with HIV or Hepatitic A, B or C.

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: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment A
Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed
의약품: TMC435 150 mg capsule
single oral dose of 150 mg TMC435 150 mg capsule
다른 이름들:
  • TMC435
실험적: Treatment B
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted
의약품: TMC435 150 mg oral suspension (20 mg/mL)
single oral dose of 150 mg TMC435 oral suspension
다른 이름들:
  • TMC435
실험적: Treatment C
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed
의약품: TMC435 150 mg oral suspension (20 mg/mL)
single oral dose of 150 mg TMC435 oral suspension
다른 이름들:
  • TMC435
실험적: Treatment D
Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed
의약품: TMC435 150 mg capsule
single oral dose of 150 mg TMC435 150 mg capsule
다른 이름들:
  • TMC435
실험적: Treatment E
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted
의약품: TMC435 150 mg oral solution (10 mg/mL)
single oral dose of 150 mg TMC435 oral solution
다른 이름들:
  • TMC435
실험적: Treatment F
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed
의약품: TMC435 150 mg oral solution (10 mg/mL)
single oral dose of 150 mg TMC435 oral solution
다른 이름들:
  • TMC435
실험적: Treatment G
Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed
의약품: TMC435 150 mg capsule
single oral dose of 150 mg TMC435 150 mg capsule
다른 이름들:
  • TMC435
실험적: Treatment H
Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed
의약품: TMC435 150 mg capsule concept K
single oral dose of 150 mg TMC435 capsule concept K
다른 이름들:
  • TMC435
실험적: Treatment I
Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed
의약품: TMC435 150 mg capsule concept L
single oral dose of 150 mg TMC435 capsule concept L
다른 이름들:
  • TMC435

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
기간: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)
4 days
Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
기간: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) of TMC435 in fed state (high-fat breakfast) versus fasted state
4 days
Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
기간: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule [150 mg] and concept L capsule [150 mg]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)
4 days

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants with adverse events
기간: 18 days
Adverse events, abnormal clinical laboratory findings, abnormalities assessed in vital signs examination, physical examination, ECG measurements were evaluated for safety and tolerability during the study
18 days
Acceptability of taste assessed by taste questionnaires
기간: Day 1 of Treatment B and E
Taste Questionnaires used to assess taste acceptability of oral suspension and solution of TMC435 under fasted conditions. Taste Questionnaire for adults: participant had to select appropriate choice (None, Weak, Moderate, Strong) for 3 different types of tastes "Sweetness, Bitterness, Flavour" and also select appropriate choice (Bad, Amost acceptable, Acceptable and Good) for the Overall taste. For pediatric participants: fill the visual analog scale by selecting appropriate choice (Dislike it very much, Dislike it a little, Not sure, Like it a little and Like it very much)
Day 1 of Treatment B and E

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen R&D Ireland

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

2012년 3월 1일

기본 완료 (실제)

2012년 5월 1일

연구 완료 (실제)

2012년 5월 1일

연구 등록 날짜

최초 제출

2012년 1월 23일

QC 기준을 충족하는 최초 제출

2012년 4월 3일

처음 게시됨 (추정)

2012년 4월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 6월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 24일

마지막으로 확인됨

2013년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CR100787
  • TMC435HPC1002 (기타 식별자: Janssen R&D Ireland)

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. .

TMC435 150 mg capsule에 대한 임상 시험

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정황

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약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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