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Completed

NCT Number: NCT04142762

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

ABI-H2158

Drug

ABI-H2158 tablets

Itraconazole

Drug

Itraconazole capsules

Rifampin

Drug

Rifampin capsules

midazolam

Drug

Midazolam syrup

ethinyl estradiol / levonorgestrel

Drug

Ethinyl Estradiol / Levonorgestrel tablets

Esomeprazole

Drug

Esomeprazole capsules

Placebo matching oral contraceptive

Drug

Placebo matching Ethinyl Estradiol / Levonorgestrel tablets

Primary outcomes

  1. Area under the plasma concentration time curve (AUC) of ABI-H2158

    Time frame: before dosing and at pre-specified time points up to Day 17

  2. Maximum observed plasma concentration (Cmax) of ABI-H2158

    Time frame: before dosing and at pre-specified time points up to Day 17

  3. AUC of Midazolam

    Time frame: before dosing and at pre-specified time points up to Day 12

  4. Cmax of Midazolam

    Time frame: before dosing and at pre-specified time points up to Day 17

  5. AUC of ethinyl estradiol and levonorgestrel

    Time frame: 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

  6. Cmax of ethinyl estradiol and levonorgestrel

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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