A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF
研究概览
简要总结
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening laboratory parameters within defined thresholds
- •Creatinine clearance must be ≥ 60 mL/min
排除标准
- •Females who are pregnant or nursing or males who have a pregnant partner
- •Infection with hepatitis B virus (HBV) or HIV
- •History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Severe Hepatic Impairment Group
Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1.
干预措施: TAF (Drug)
Matched Normal Hepatic Function Group
Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.
干预措施: TAF (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF
时间窗: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
AUCinf is defined as the concentration of drug extrapolated to infinite time.
PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF
时间窗: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
Cmax is defined as the maximum concentration of drug.
PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF
时间窗: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
次要结局
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(Day 1 plus 30 days)
- Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities(Day 1 plus 30 days)