A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
A Multi Center, Sequential, Open-Label, Multiple-Dose Study of Setrobuvir (STV) Alone and With Co-Administration of Ritonavir-boosted Danoprevir to Evaluate the Safety, Tolerability and Pharmacokinetics of STV, DNV, and Ritonavir (RTV) in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male and female adults, 18-65 years of age, inclusive
- Weight >/= 45.0 kg
- Body mass index (BMI) 18.0 - 35.0 kg/m2, inclusive
- Females of childbearing potential and males and their female partners of childbearing potential must agree to use two forms of non-hormonal contraception as defined by protocol
- Subjects with a history of substance abuse may be enrolled provided they have not abused drugs or alcohol for at least 6 months
- Healthy subjects only:
Medical history without major recent or ongoing pathology Laboratory values at screening and Day -1 within the normal range or showing no clinically relevant deviations
- Subjects with hepatic impairment only:
Stable mild liver disease (Child-Pugh A) of cryptogenic, post-hepatic, hepatitis B/C, or alcoholic origin Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days Must be on stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication
Exclusion Criteria:
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Active infection or febrile illness </= 10 days prior to the first dose of study medication
- Uncontrolled/untreated hypertension
- Inadequate renal function
- Positive urine drug screen or positive breath alcohol test at screening and on Day -1 of each period
- An average alcohol intake of more than 2 units per day or 14 units per week until 48 hours prior to enrollment
- History of any significant drug-related allergy or hepatotoxicity
- Participation in other clinical studies with an investigational drug or new chemical entity within 3 months (6 months for biologic therapies) prior to the first dose of study medication
- Positive for HIV infection
- Any clinically significant cardiovascular or cerebrovascular disease
- Healthy subjects only:
Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, absorption of medication, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Positive screening test for HBsAg or HCV antibody
- Subjects with hepatic impairment only:
Severe ascites at screening or Day -1 History of or current severe hepatic encephalopathy (Grade 3 or higher) Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver Positive screening test for HCV antigen
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:非ランダム化
- 介入モデル:並列代入
- 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:A: setrobuvir
|
200 mg orally every 12 hours
|
|
実験的:B: setrobuvir + DNV/r
|
200 mg orally every 12 hours
100 mg orally every 12 hours
100 mg orally every 12 hours
|
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 |
|---|---|
|
Safety: Incidence of adverse events
時間枠:approximately 40 days
|
approximately 40 days
|
|
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
時間枠:up to 16 days
|
up to 16 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Pharmacokinetics: Time to maximum plasma concentration (tmax)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Elimination half-life (t1/2)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)
時間枠:up to 16 days
|
up to 16 days
|
|
Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)
時間枠:up to 12 days
|
up to 12 days
|
|
Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)
時間枠:up to 12 days
|
up to 12 days
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NP28326
- 2012-002283-28 (EudraCT番号)
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