NCT04142762

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H2158	ABI-H2158 tablets
DRUG	Itraconazole	Itraconazole capsules
DRUG	Rifampin	Rifampin capsules
DRUG	Midazolam	Midazolam syrup
DRUG	Ethinyl Estradiol / Levonorgestrel	Ethinyl Estradiol / Levonorgestrel tablets
DRUG	Esomeprazole	Esomeprazole capsules
DRUG	Placebo matching oral contraceptive	Placebo matching Ethinyl Estradiol / Levonorgestrel tablets

Timeline

• Start date: 2019-10-18
• Primary completion: 2020-01-12
• Completion: 2020-01-29
• First posted: 2019-10-29
• Last updated: 2020-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study