A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
2013年6月24日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
72
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Harrow、イギリス
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Treatment A
Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
他の名前：
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実験的：Treatment B
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral suspension
他の名前：
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実験的：Treatment C
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed
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single oral dose of 150 mg TMC435 oral suspension
他の名前：
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実験的：Treatment D
Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
他の名前：
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実験的：Treatment E
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral solution
他の名前：
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実験的：Treatment F
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed
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single oral dose of 150 mg TMC435 oral solution
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実験的：Treatment G
Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
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実験的：Treatment H
Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed
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single oral dose of 150 mg TMC435 capsule concept K
他の名前：
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実験的：Treatment I
Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed
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single oral dose of 150 mg TMC435 capsule concept L
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
時間枠：4 days
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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)
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4 days
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Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
時間枠：4 days
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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
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4 days
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Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
時間枠：4 days
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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)
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4 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of participants with adverse events
時間枠：18 days
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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
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18 days
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Acceptability of taste assessed by taste questionnaires
時間枠：Day 1 of Treatment B and E
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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)
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Day 1 of Treatment B and E
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年3月1日
一次修了 (実際)
2012年5月1日
研究の完了 (実際)
2012年5月1日
試験登録日
最初に提出
2012年1月23日
QC基準を満たした最初の提出物
2012年4月3日
最初の投稿 (見積もり)
2012年4月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年6月25日
QC基準を満たした最後の更新が送信されました
2013年6月24日
最終確認日
2013年6月1日
詳しくは
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