Chronic Hepatitis BPhase 1NCT04637139
A Study to Evaluate the Mass Balance Absorption and AME of VBR
A Phase 1 study testing Vebicorvir (VBR) in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in United States.
Trial summary
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Vebicorvir (VBR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 22 Dec 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass)
- Clinically significant abnormal medical history
- History of cancer that has not been in full remission for >5 years
- Acute illness within 14 days prior to study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase 1 Study in Healthy Adult Male Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Vebicorvir Following Single Oral Dose Administration
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
- Conditions
- Chronic Hepatitis B
- Being tested
- Vebicorvir (VBR)
- Keywords
- CHB, HBV, hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vebicorvir (VBR)Drug
300mg Vebicovir containing 2 µCi [14C]VBR.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | VBR 300 mg solution containing 2 µCi [14C]VBR Receives: Drug: Vebicorvir (VBR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
Measured: Before dosing and at prespecified time intervals up to 168 hours after dosing
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C)
Measured: Before dosing and at prespecified time intervals up to 168 hours after dosing
Secondary outcomes (2)
Number of Participants with One or More Adverse Events
Measured: Up to 168 hours
Number of Participants Discontinued from the Study Due to an Adverse Event
Measured: Up to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Dec 2020
- Primary completion22 Dec 2020
- Study completion22 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637139
- Sponsor's protocol ID
- ABI H0731 108
- Status last verified
- Jan 2021
- First submitted
- 30 Oct 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1 Study in Healthy Adult Male Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Vebicorvir Following Single Oral Dose Administration
- ClinicalTrials.gov ID
- NCT04637139
- Acronym / sponsor ID
- ABI H0731 108
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, HBV, hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 19 Nov 2020 (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 Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Vebicorvir (VBR)VBR 300 mg solution containing 2 µCi [14C]VBR |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass)
- Clinically significant abnormal medical history
- History of cancer that has not been in full remission for >5 years
- Acute illness within 14 days prior to study drug administration
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 |
|---|---|---|
| Vebicorvir (VBR)300mg Vebicovir containing 2 µCi [14C]VBR. | Drug | Group 1 |
Primary outcome
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
Time frame: Before dosing and at prespecified time intervals up to 168 hours after dosing
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C)
Time frame: Before dosing and at prespecified time intervals up to 168 hours after dosing
2 secondary outcomes
Number of Participants with One or More Adverse Events
Time frame: Up to 168 hours
Number of Participants Discontinued from the Study Due to an Adverse Event
Time frame: Up to 168 hours
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 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vebicorvir (VBR) 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 0 inclusion and 4 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 12 Jan 2021. 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?
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C) (time frame: Before dosing and at prespecified time intervals up to 168 hours after dosing). 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 12 Jan 2021.