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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT04142762

Run by

Assembly Biosciences

People needed

80

Starts

2019-10-18

Expected to finish

2020-01-29

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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