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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABI-H2158
Itraconazole
Rifampin
Midazolam
Ethinyl Estradiol / Levonorgestrel
Esomeprazole
Placebo matching oral contraceptive
Sponsored by
Assembly Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Celerion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: ABI-H2158 + Itraconazole

Cohort 2: ABI-H2158 + Rifampin

Cohort 3: ABI-H2158 + Esomeprazole

Cohort 4: ABI-H2158 + Midazolam

Cohort 5: ABI-H2158 + Oral Contraceptive

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Area under the plasma concentration time curve (AUC) of ABI-H2158
Maximum observed plasma concentration (Cmax) of ABI-H2158
AUC of Midazolam
Cmax of Midazolam
AUC of ethinyl estradiol and levonorgestrel
Cmax of ethinyl estradiol and levonorgestrel

Secondary Outcome Measures

Full Information

First Posted
October 16, 2019
Last Updated
March 3, 2020
Sponsor
Assembly Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04142762
Brief Title
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assembly Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: ABI-H2158 + Itraconazole
Arm Type
Experimental
Arm Description
Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13
Arm Title
Cohort 2: ABI-H2158 + Rifampin
Arm Type
Experimental
Arm Description
Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16
Arm Title
Cohort 3: ABI-H2158 + Esomeprazole
Arm Type
Experimental
Arm Description
Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11
Arm Title
Cohort 4: ABI-H2158 + Midazolam
Arm Type
Experimental
Arm Description
Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11
Arm Title
Cohort 5: ABI-H2158 + Oral Contraceptive
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
ABI-H2158
Intervention Description
ABI-H2158 tablets
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Description
Itraconazole capsules
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Rifampin capsules
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam syrup
Intervention Type
Drug
Intervention Name(s)
Ethinyl Estradiol / Levonorgestrel
Intervention Description
Ethinyl Estradiol / Levonorgestrel tablets
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole capsules
Intervention Type
Drug
Intervention Name(s)
Placebo matching oral contraceptive
Intervention Description
Placebo matching Ethinyl Estradiol / Levonorgestrel tablets
Primary Outcome Measure Information:
Title
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
Title
Maximum observed plasma concentration (Cmax) of ABI-H2158
Time Frame
before dosing and at pre-specified time points up to Day 17
Title
AUC of Midazolam
Time Frame
before dosing and at pre-specified time points up to Day 12
Title
Cmax of Midazolam
Time Frame
before dosing and at pre-specified time points up to Day 17
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Lead
Organizational Affiliation
Assembly Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Celerion
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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