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VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir

2012年10月13日 更新者:Tibotec BVBA

A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state

The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.

調査の概要

詳細な説明

This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20 healthy participants. Each individual participant will receive two treatments: Treatment A (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8 hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11). Half of the participants will receive first Treatment A and then Treatment B; the other half will receive first Treatment B and then Treatment A. There will be a washout period of at least 14 days between the 2 sessions. The screening period will be maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples will be taken for determination of the levels of raltegravir in the blood. Predose pharmacokinetic samples will be collected on other days during the treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the heart), drug and alcohol screenings, and by assessing how the participant is feeling. In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

研究の種類

介入

入学 (実際)

21

段階

  • フェーズ 1

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 on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening
  • A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
  • Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding
  • Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug
  • Be non-smoking for at least 3 months prior to selection.

Exclusion Criteria:

  • Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication
  • Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day
  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
  • Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.

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
実験的:001
Treatment sequence AB Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
実験的:002
Treatment sequence BA Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

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
時間枠
Blood levels of telaprevir and raltegravir when given alone versus when given together
時間枠:Day 7 of Treatment A
Day 7 of Treatment A
Blood levels of telaprevir and raltegravir when given alone versus when given together
時間枠:Day 4 of Treatment B
Day 4 of Treatment B
Blood levels of telaprevir and raltegravir when given alone versus when given together
時間枠:Day 11 of Treatment B
Day 11 of Treatment B

二次結果の測定

結果測定
時間枠
Percentage of participants with a given adverse event as a measure of safety and tolerability
時間枠:From screening to end of study
From screening to end of study
Clinical laboratory abnormalities as a measure of safety and tolerability
時間枠:At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
Clinical laboratory abnormalities as a measure of safety and tolerability
時間枠:On Days 1 and 7 (Treatment A)
On Days 1 and 7 (Treatment A)
Clinical laboratory abnormalities as a measure of safety and tolerability
時間枠:On Days 1, 4, and 11 (Treatment B)
On Days 1, 4, and 11 (Treatment B)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
時間枠:At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
時間枠:On Days 1 and 7 (Treatment A)
On Days 1 and 7 (Treatment A)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
時間枠:On Days 1, 4, and 11 (Treatment B)
On Days 1, 4, and 11 (Treatment B)
Physical examination findings and changes from baseline as a measure of safety and tolerability
時間枠:At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B)
At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B)

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。

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

2010年12月1日

研究の完了 (実際)

2011年4月1日

試験登録日

最初に提出

2010年12月2日

QC基準を満たした最初の提出物

2010年12月2日

最初の投稿 (見積もり)

2010年12月3日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年10月16日

QC基準を満たした最後の更新が送信されました

2012年10月13日

最終確認日

2012年10月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

C型肝炎の臨床試験

Treatment sequence ABの臨床試験

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