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

NCT04142762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-03-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Study Lead · Assembly Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2020-01-12
Completion
2020-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04142762 on ClinicalTrials.gov