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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04142762

Enrollment

Registered

2019-10-29

Start date

2019-10-18

Completion date

2020-01-29

Last updated

2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief 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.

Interventions

DRUGABI-H2158

ABI-H2158 tablets

DRUGItraconazole

Itraconazole capsules

DRUGRifampin

Rifampin capsules

DRUGMidazolam

Midazolam syrup

DRUGEthinyl Estradiol / Levonorgestrel

Ethinyl Estradiol / Levonorgestrel tablets

DRUGEsomeprazole

Esomeprazole capsules

DRUGPlacebo matching oral contraceptive

Placebo matching Ethinyl Estradiol / Levonorgestrel tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration time curve (AUC) of ABI-H2158	before dosing and at pre-specified time points up to Day 17
Maximum observed plasma concentration (Cmax) of ABI-H2158	before dosing and at pre-specified time points up to Day 17
AUC of Midazolam	before dosing and at pre-specified time points up to Day 12
Cmax of Midazolam	before dosing and at pre-specified time points up to Day 17
AUC of ethinyl estradiol and levonorgestrel	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	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026