Chronic Hepatitis BPhase 1NCT04083716
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
A Phase 1 study testing ABI-H2158 Reference Formulation and ABI-H2158 Test Formulation in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in United States.
Trial summary
This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions. 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 Reference Formulation and ABI-H2158 Test Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 7 Oct 2019
- 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
- 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Who cannot join
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adult Subjects
This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation
- 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-H2158 Reference FormulationDrug
ABI-H2158 tablets Reference Formulation
ABI-H2158 Test FormulationDrug
ABI-H2158 tablets Test Formulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ABI-H2158 Reference Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation after a high-fat meal on Day 15 (Period 3) Receives: Drug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test Formulation |
| Group 2 | Experimental | ABI-H2158 Test Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation after a high-fat meal on Day 8 (Period 2), then ABI-H2158 Reference Formulation in a fasting state on Day 15 (Period 3) Receives: Drug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test Formulation |
| Group 3 | Experimental | ABI-H2158 Test Formulation after a high-fat meal on Day 1 (Period 1), then ABI-H2158 Reference Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation in a fasting state on Day 15 (Period 3) Receives: Drug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test Formulation |
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: Relative Bioavailability and Food Effect
Measured: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
Maximum observed plasma concentration (Cmax) of ABI-H2158: Relative Bioavailability and Food Effect
Measured: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start6 Sep 2019
- Primary completion5 Oct 2019
- Study completion7 Oct 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Evanchik, Study director, Assembly Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083716
- Sponsor's protocol ID
- ABI-H2158-102
- Status last verified
- Nov 2019
- First submitted
- 6 Sep 2019
- Last updated
- 29 Nov 2019
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04083716
- Acronym / sponsor ID
- ABI-H2158-102
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 10 Sep 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 the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ABI-H2158 Reference Formulation, Drug: ABI-H2158 Test FormulationABI-H2158 Reference Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation after a high-fat meal on Day 15 (Period 3) |
| Group 2 | Experimental | Drug: ABI-H2158 Reference Formulation, Drug: ABI-H2158 Test FormulationABI-H2158 Test Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation after a high-fat meal on Day 8 (Period 2), then ABI-H2158 Reference Formulation in a fasting state on Day 15 (Period 3) |
| Group 3 | Experimental | Drug: ABI-H2158 Reference Formulation, Drug: ABI-H2158 Test FormulationABI-H2158 Test Formulation after a high-fat meal on Day 1 (Period 1), then ABI-H2158 Reference Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation in a fasting state on Day 15 (Period 3) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Key exclusion criteria (2 listed)
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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-H2158 Reference FormulationABI-H2158 tablets Reference Formulation | Drug | Group 1, Group 2, Group 3 |
| ABI-H2158 Test FormulationABI-H2158 tablets Test Formulation | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Area under the plasma concentration time curve (AUC) of ABI-H2158: Relative Bioavailability and Food Effect
Time frame: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
Maximum observed plasma concentration (Cmax) of ABI-H2158: Relative Bioavailability and Food Effect
Time frame: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
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 29 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Marc Evanchik 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 Reference Formulation and ABI-H2158 Test Formulation 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 1 inclusion and 2 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 29 Nov 2019. 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: Relative Bioavailability and Food Effect (time frame: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15). The study lists 2 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 29 Nov 2019.