A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- C0 [predose]
研究概览
简要总结
A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Parts 1 and 2 are double blinded and randomized. Parts 3, 5, and 6 are open label and non-randomized. Part 4 is partially singled blinded non-randomized. Participants are blinded.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ALG-097558 and Carbamazepine
Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers
干预措施: ALG-097558 (Drug)
ALG-097558
Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days
干预措施: ALG-097558 (Drug)
Placebo
Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days
干预措施: Placebo (Drug)
ALG-097558 and Midazolam
Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers
干预措施: ALG-097558 (Drug)
ALG-097558 and Midazolam
Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers
干预措施: Midazolam (Drug)
ALG-097558, Placebo, and, Itraconazole
Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
干预措施: ALG-097558 (Drug)
ALG-097558, Placebo, and, Itraconazole
Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
干预措施: Placebo (Drug)
ALG-097558, Placebo, and, Itraconazole
Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
干预措施: Itraconazole (Drug)
ALG-097558 and Carbamazepine
Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers
干预措施: Carbamazepine (Drug)
ALG-097558 Bioavailability
Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers
干预措施: ALG-097558 in solution formulation (Drug)
ALG-097558 Bioavailability
Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers
干预措施: ALG-097558 in tablet formulation (Drug)
结局指标
主要结局
C0 [predose]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Half-life [t1/2]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to 17 days for Part 6
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Area under the concentration time curve [AUC]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Maximum plasma concentration [Cmax]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Time to maximum plasma concentration [Tmax]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Minimum plasma concentration [Cmin]
时间窗: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
次要结局
- Minimum plasma concentration [Cmin](Predose (-0.75 hours) up to 19 days)
- Time to maximum plasma concentration [Tmax](Predose (-0.75 hours) up to 19 days)
- Half-life [t1/2](Predose (-0.75 hours) up to 19 days)
- C0 [predose](Predose (-0.75 hours) up to 19 days)
- Dose Proportionality(Predose (-0.75 hours) up to 19 days)
- Maximum plasma concentration [Cmax](Predose (-0.75 hours) up to 19 days)
- Area under the concentration time curve [AUC](Predose (-0.75 hours) up to 19 days)