NCT03163550已完成1 期
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
研究概览
简要总结
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
- •Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
- •Body mass index (BMI) of ≥19 kg/m^2 to ≤32 kg/m^2 and weight ≥50 kg to ≤125 kg
- •Normal renal function as determined by creatinine clearance (CLcr) rate
排除标准
- •Pregnant women
- •History of any hepatic or biliary disorder or disease
- •Any condition that could possibly affect oral drug absorption
- •Unstable cardiovascular disease
- •Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- •HIV positive
- •Active malignancy
研究组 & 干预措施
Cohort 1
Experimental
Healthy volunteers
干预措施: ACHN-383 (Drug)
Cohort 1
Experimental
Healthy volunteers
干预措施: ACHN-789 (Drug)
Cohort 1
Experimental
Healthy volunteers
干预措施: Placebo (Drug)
Cohort 2
Experimental
Healthy volunteers
干预措施: ACHN-383 (Drug)
Cohort 2
Experimental
Healthy volunteers
干预措施: ACHN-789 (Drug)
Cohort 2
Experimental
Healthy volunteers
干预措施: Placebo (Drug)
Cohort 3
Experimental
Healthy volunteers
干预措施: ACHN-383 (Drug)
Cohort 3
Experimental
Healthy volunteers
干预措施: ACHN-789 (Drug)
Cohort 3
Experimental
Healthy volunteers
干预措施: Placebo (Drug)
Cohort 4
Experimental
Healthy volunteers
干预措施: ACHN-383 (Drug)
Cohort 4
Experimental
Healthy volunteers
干预措施: ACHN-789 (Drug)
Cohort 4
Experimental
Healthy volunteers
干预措施: Placebo (Drug)
Cohort 5
Experimental
Healthy volunteers
干预措施: ACHN-383 (Drug)
Cohort 5
Experimental
Healthy volunteers
干预措施: ACHN-789 (Drug)
Cohort 5
Experimental
Healthy volunteers
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
时间窗: 26 days
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
时间窗: 26 days
Incidence and severity of adverse events
时间窗: 26 days
Changes from baseline in the QTcF interval
时间窗: 19 days
次要结局
- PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789(1 day)
- PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789(1 day)
- PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383(3 days)
- PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789(1 day)
- PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383(3 days)
- PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383(3 days)
- PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383(3 days)
- PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789(1 day)
- PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789(1 day)
- PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789(1 day)
- PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383(3 days)
- PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- Urine concentrations of ACHN-789 after single dose administration(1 day)
- PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789(1 day)
- PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383(3 days)
- PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789(1 day)
- PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383(3 days)
- PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383(3 days)
- PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently(5 days)
- PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal(6 days)
- PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently(19 days)
- PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- Urine concentrations of ACHN-383 after single-dose administration(3 days)
- PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 days)
- Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently(5 days)
研究者
研究点 (1)
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