Chronic Hepatitis BPhase 1NCT04142762
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
A Phase 1 study testing ABI-H2158, Itraconazole and Rifampin in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-H2158, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 29 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ABI-H2158, Itraconazole, Rifampin, Midazolam, Ethinyl Estradiol / Levonorgestrel
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-H2158Drug
ABI-H2158 tablets
ItraconazoleDrug
Itraconazole capsules
RifampinDrug
Rifampin capsules
MidazolamDrug
Midazolam syrup
Ethinyl Estradiol / LevonorgestrelDrug
Ethinyl Estradiol / Levonorgestrel tablets
EsomeprazoleDrug
Esomeprazole capsules
Placebo matching oral contraceptiveDrug
Placebo matching Ethinyl Estradiol / Levonorgestrel tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ABI-H2158 + Itraconazole | Experimental | Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13 Receives: Drug: ABI-H2158; Drug: Itraconazole |
| Cohort 2: ABI-H2158 + Rifampin | Experimental | Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16 Receives: Drug: ABI-H2158; Drug: Rifampin |
| Cohort 3: ABI-H2158 + Esomeprazole | Experimental | Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11 Receives: Drug: ABI-H2158; Drug: Esomeprazole |
| Cohort 4: ABI-H2158 + Midazolam | Experimental | Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11 Receives: Drug: ABI-H2158; Drug: Midazolam |
| Cohort 5: ABI-H2158 + Oral Contraceptive | Experimental | 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 Receives: Drug: ABI-H2158; Drug: Ethinyl Estradiol / Levonorgestrel; Drug: Placebo matching oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve (AUC) of ABI-H2158
Measured: before dosing and at pre-specified time points up to Day 17
Maximum observed plasma concentration (Cmax) of ABI-H2158
Measured: before dosing and at pre-specified time points up to Day 17
AUC of Midazolam
Measured: before dosing and at pre-specified time points up to Day 12
Cmax of Midazolam
Measured: before dosing and at pre-specified time points up to Day 17
AUC of ethinyl estradiol and levonorgestrel
Measured: 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
Cmax of ethinyl estradiol and levonorgestrel
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start18 Oct 2019
- Primary completion12 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Lead, Study director, Assembly Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142762
- Sponsor's protocol ID
- ABI-H2158-103
- Status last verified
- Mar 2020
- First submitted
- 16 Oct 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142762
- Acronym / sponsor ID
- ABI-H2158-103
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ABI-H2158 + Itraconazole | Experimental | Drug: ABI-H2158, Drug: ItraconazoleOral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13 |
| Cohort 2: ABI-H2158 + Rifampin | Experimental | Drug: ABI-H2158, Drug: RifampinOral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16 |
| Cohort 3: ABI-H2158 + Esomeprazole | Experimental | Drug: ABI-H2158, Drug: EsomeprazoleOral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11 |
| Cohort 4: ABI-H2158 + Midazolam | Experimental | Drug: ABI-H2158, Drug: MidazolamOral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11 |
| Cohort 5: ABI-H2158 + Oral Contraceptive | Experimental | Drug: ABI-H2158, Drug: Ethinyl Estradiol / Levonorgestrel, Drug: Placebo matching oral contraceptiveCycle 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-H2158ABI-H2158 tablets | Drug | 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 |
| ItraconazoleItraconazole capsules | Drug | Cohort 1: ABI-H2158 + Itraconazole |
| RifampinRifampin capsules | Drug | Cohort 2: ABI-H2158 + Rifampin |
| MidazolamMidazolam syrup | Drug | Cohort 4: ABI-H2158 + Midazolam |
| Ethinyl Estradiol / LevonorgestrelEthinyl Estradiol / Levonorgestrel tablets | Drug | Cohort 5: ABI-H2158 + Oral Contraceptive |
| EsomeprazoleEsomeprazole capsules | Drug | Cohort 3: ABI-H2158 + Esomeprazole |
| Placebo matching oral contraceptivePlacebo matching Ethinyl Estradiol / Levonorgestrel tablets | Drug | Cohort 5: ABI-H2158 + Oral Contraceptive |
Primary outcome
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
Maximum observed plasma concentration (Cmax) of ABI-H2158
Time frame: before dosing and at pre-specified time points up to Day 17
AUC of Midazolam
Time frame: before dosing and at pre-specified time points up to Day 12
Cmax of Midazolam
Time frame: before dosing and at pre-specified time points up to Day 17
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Lead study director
Assembly Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-H2158, Itraconazole and Rifampin in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.