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

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Rifampin; Drug: Placebo matching oral contraceptive; Drug: Ethinyl Estradiol / Levonorgestrel; Drug: ABI-H2158; Drug: Midazolam; Drug: Itraconazole; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04142762

ABI-H2158-103

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 5 patient groups

Cohort 1: ABI-H2158 + Itraconazole

Experimental group

Description:

Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13

Treatment:

Drug: ABI-H2158

Drug: Itraconazole

Cohort 2: ABI-H2158 + Rifampin

Experimental group

Description:

Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16

Treatment:

Drug: Rifampin

Drug: ABI-H2158

Cohort 3: ABI-H2158 + Esomeprazole

Experimental group

Description:

Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11

Treatment:

Drug: Esomeprazole

Drug: ABI-H2158

Cohort 4: ABI-H2158 + Midazolam

Experimental group

Description:

Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11

Treatment:

Drug: ABI-H2158

Drug: Midazolam

Cohort 5: ABI-H2158 + Oral Contraceptive

Experimental group

Description:

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

Treatment:

Drug: ABI-H2158

Drug: Ethinyl Estradiol / Levonorgestrel

Drug: Placebo matching oral contraceptive