drugset / Trial / NCT04142762
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2019-10-18
- Primary completion
- 2020-01-12
- Completion
- 2020-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABI-H2158 | Unknown | — | Oral |
| Subject | Esomeprazole | Small molecule | — | Oral |
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Levonorgestrel | Small molecule | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Rifampicin | Small molecule | — | Oral |
| Subject | ethinyl estradiol | Small molecule | — | Oral |