A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State
2012年11月30日 更新者：Tibotec BVBA
A Phase I, Open-Label, Single-Sequence Drug-Drug Interaction Trial in Subjects on Stable Methadone Maintenance Therapy, to Investigate the Potential Interaction Between Telaprevir 750 mg q8h and Methadone, at Steady-State
The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.
調査の概要
詳細な説明
This is a Phase 1, open-label (all people know the identity of the intervention), single-sequence study to evaluate the potential interaction of steady-state telaprevir on the steady-state pharmacokinetics of methadone.
The study consists of 3 phases: the screening phase (within 21 days prior to the start of supervised methadone intake on Day -14), treatment phase, and follow-up phase.
Participants on stable methadone maintenance therapy will be enrolled in this study and their methadone doses will not be changed starting at Day -14.
During the treatment phase, telaprevir will be added for 7 days (from Day 1 to Day 7) to participants' current methadone therapy.
The methadone dosage will not to be changed from Day -14 until Day 7. All the intakes of methadone and telaprevir will be supervised and pharmacokinetic parameters will be measured during the study.
Safety evaluations for adverse events, clinical laboratory tests, alcohol breath test, cardiovascular safety, and other evaluations (physical examination, and pharmacodynamic assessments) will be performed throughout the study.
The total duration of the study for each participant is approximately 60 days.
研究の種類
介入
入学 (実際)
18
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:
- Must receive once daily oral methadone maintenance therapy at a stable individualized dose of 30 to 130 mg for at least 2 weeks prior to screening, formulated as commercially available tablets or solution
- Must agree not to change the current methadone dose from screening until Day 7 included to have a daily observed and documented methadone intake from Day -14 until Day 8 and a daily observed and documented telaprevir intake from Day 1 until Day 7
- Participants have to obtain approval for participation from his/her addiction physician, and the addiction physician has to agree to provide medical care for the participant after discharge from study center
- General medical condition must not interfere with the assessments and the completion of the study
- Health assessments will be done on the basis of physical examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
Exclusion Criteria:
- History of any illness that could confound the results of the study or pose an additional risk in administering study medication to the participant, for eg, history of relevant medication or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology or history of mental disease
- Consumption of herbal medications or dietary supplements, vitamins, and grapefruit or grapefruit juice, apple juice or orange juice within 14 days before Day -1
- Current alcohol use, which, in the assessment of the investigator, could compromise participant's safety or compliance with the study protocol procedures
- Test positive for drugs of abuse such as cocaine, amphetamines, barbiturates, benzodiazepines, or opiates on Day -2 unless explained by allowed concomitant medications
- Participation in a clinical study involving administration of an investigational medication within 60 days or 5 half-lives (whichever was longer) prior to the screening visit
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：なし
- 介入モデル：単一グループの割り当て
- 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：Telaprevir + Methadone
Patients will receive telaprevir 750 mg orally, every 8 hours from Day 1 to Day 7, along with methadone 30 to 130 mg, once daily.
|
Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily.
Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days.
|
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 |
|---|---|---|
|
Maximum plasma concentration (Cmax) of telaprevir
時間枠：On Day 7
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Pharmacokinetic parameter Cmax of telaprevir is measured when telaprevir will be administered at 750 mg every 8 hours for 7 days added to stable methadone maintenance therapy.
|
On Day 7
|
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Minimum plasma concentration (Cmin) of telaprevir
時間枠：On Day 7
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Pharmacokinetic parameter Cmin of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
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On Day 7
|
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Area under the plasma concentration-time curve (AUC) of telaprevir
時間枠：On Day 7
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Pharmacokinetic parameter AUC of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
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On Day 7
|
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Cmax of R-methadone
時間枠：Day -1 and Day 7
|
Pharmacokinetic parameter Cmax of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
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Day -1 and Day 7
|
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Cmin of R-methadone
時間枠：Day -1 and Day 7
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Pharmacokinetic parameter Cmin of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
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Day -1 and Day 7
|
|
AUC of R-methadone
時間枠：Day -1 and Day 7
|
Pharmacokinetic parameter AUC of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
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Day -1 and Day 7
|
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Cmax of S-methadone
時間枠：Day -1 and Day 7
|
Pharmacokinetic parameter Cmax of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
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Day -1 and Day 7
|
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Cmin of S-methadone
時間枠：Day -1 and Day 7
|
Pharmacokinetic parameter Cmin of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
|
Day -1 and Day 7
|
|
AUC of S-methadone
時間枠：Day -1 and Day 7
|
Pharmacokinetic parameter AUC of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
|
Day -1 and Day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Short Opiate Withdrawal Scale [SOWS]
時間枠：Day -7, and Day -2 to Day 7
|
Pharmacodynamic assessments of methadone withdrawal are performed by means of SOWS.
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Day -7, and Day -2 to Day 7
|
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Desires for Drugs Questionnaire [DDQ]
時間枠：Day -7, and Day -2 to Day 7
|
Pharmacodynamic assessments of methadone withdrawal are performed by means of DDQ.
|
Day -7, and Day -2 to Day 7
|
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Pupillometry
時間枠：Day -1, Day 2, Day 4, and Day 7
|
Pharmacodynamic assessments of methadone withdrawal are performed by means of pupillometry.
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Day -1, Day 2, Day 4, and Day 7
|
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Number of participants with adverse events
時間枠：Up to 60 days
|
Up to 60 days
|
協力者と研究者
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2009年7月1日
一次修了 (実際)
2009年11月1日
研究の完了 (実際)
2009年12月1日
試験登録日
最初に提出
2009年7月2日
QC基準を満たした最初の提出物
2009年7月2日
最初の投稿 (見積もり)
2009年7月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月3日
QC基準を満たした最後の更新が送信されました
2012年11月30日
最終確認日
2012年11月1日
詳しくは
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