A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the concentration time curve [AUC]
研究概览
简要总结
This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs).
In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.
In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period.
The 2 parts may be conducted in parallel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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-000184
Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator
干预措施: ALG-000184 (Drug)
Carbamazepine
Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184
干预措施: Carbamazepine (Drug)
Carbamazepine
Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184
干预措施: ALG-000184 (Drug)
Itraconazole
Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.
干预措施: Itraconazole (Sporanox) (Drug)
Itraconazole
Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.
干预措施: ALG-000184 (Drug)
结局指标
主要结局
Area under the concentration time curve [AUC]
时间窗: Up to 29 days.
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Time to maximum plasma concentration [Tmax]
时间窗: Up to 24 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)
Maximum plasma concentration [Cmax]
时间窗: Up to 24 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)
Minimum plasma concentration [Cmin]
时间窗: Up to 29 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
C0 [predose]
时间窗: Up to 29 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Half-life [t1/2]
时间窗: Up to 29 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 29 days for Part 2)
- Mean Change from Baseline QTc at different exposure levels(Up to 29 days for Part 2.)