A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate CYP3A4-Mediated, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration time curve (AUC) of ABI-H2158
研究概览
简要总结
This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
- •Cohort 5: naive to the use of oral contraceptives.
排除标准
- •Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
研究组 & 干预措施
Cohort 4: ABI-H2158 + Midazolam
Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11
干预措施: Midazolam (Drug)
Cohort 1: ABI-H2158 + Itraconazole
Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13
干预措施: ABI-H2158 (Drug)
Cohort 1: ABI-H2158 + Itraconazole
Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13
干预措施: Itraconazole (Drug)
Cohort 2: ABI-H2158 + Rifampin
Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16
干预措施: ABI-H2158 (Drug)
Cohort 2: ABI-H2158 + Rifampin
Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16
干预措施: Rifampin (Drug)
Cohort 3: ABI-H2158 + Esomeprazole
Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11
干预措施: ABI-H2158 (Drug)
Cohort 3: ABI-H2158 + Esomeprazole
Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11
干预措施: Esomeprazole (Drug)
Cohort 4: ABI-H2158 + Midazolam
Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11
干预措施: ABI-H2158 (Drug)
Cohort 5: ABI-H2158 + Oral Contraceptive
Cycle 1: active oral contraceptive (ethinyl estradiol/levonorgestrel) QD on Days 1 through 21 and oral placebo QD on Days 22 through 28; Cycle 2: active oral contraceptive QD on Days 1 through 21, oral placebo QD on Days 22 through 26, and oral ABI-H2158 QD on Days 11 through 24
干预措施: ABI-H2158 (Drug)
Cohort 5: ABI-H2158 + Oral Contraceptive
Cycle 1: active oral contraceptive (ethinyl estradiol/levonorgestrel) QD on Days 1 through 21 and oral placebo QD on Days 22 through 28; Cycle 2: active oral contraceptive QD on Days 1 through 21, oral placebo QD on Days 22 through 26, and oral ABI-H2158 QD on Days 11 through 24
干预措施: Ethinyl Estradiol / Levonorgestrel (Drug)
Cohort 5: ABI-H2158 + Oral Contraceptive
Cycle 1: active oral contraceptive (ethinyl estradiol/levonorgestrel) QD on Days 1 through 21 and oral placebo QD on Days 22 through 28; Cycle 2: active oral contraceptive QD on Days 1 through 21, oral placebo QD on Days 22 through 26, and oral ABI-H2158 QD on Days 11 through 24
干预措施: Placebo matching oral contraceptive (Drug)
结局指标
主要结局
Area under the plasma concentration time curve (AUC) of ABI-H2158
时间窗: before dosing and at pre-specified time points up to Day 17
Maximum observed plasma concentration (Cmax) of ABI-H2158
时间窗: before dosing and at pre-specified time points up to Day 17
AUC of Midazolam
时间窗: before dosing and at pre-specified time points up to Day 12
Cmax of Midazolam
时间窗: before dosing and at pre-specified time points up to Day 17
AUC of ethinyl estradiol and levonorgestrel
时间窗: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
Cmax of ethinyl estradiol and levonorgestrel
时间窗: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
次要结局
未报告次要终点