A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

• Status: Completed
• Trial end date: 2020-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assembly Biosciences
• Treatments: Contraceptive Agents; Contraceptives, Oral; Esomeprazole; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Hydroxyitraconazole; Itraconazole; Levonorgestrel; Midazolam; Polyestradiol phosphate; Rifampin

Criteria

Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

2. Cohort 5: naive to the use of oral contraceptives.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.