Back to resultsA Study to Evaluate the Mass Balance Absorption and AME of VBR
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vebicorvir (VBR)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring CHB, HBV, hepatitis B
Eligibility Criteria
- Consent
- Male between 18 and 55 years of age (inclusive) at the time of Screening
- Body mass index (BMI) between ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight between ≥55.0 kg and ≤100.0 kg at Screening
- Considered to be in good health by the Investigator
Exclusion Criteria:
- 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
Sites / Locations
- Pharmaron CPC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1
Arm Description
VBR 300 mg solution containing 2 µCi [14C]VBR
Outcomes
Primary Outcome Measures
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C)
Secondary Outcome Measures
Number of Participants with One or More Adverse Events
Number of Participants Discontinued from the Study Due to an Adverse Event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637139
Brief Title
A Study to Evaluate the Mass Balance Absorption and AME of VBR
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 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 Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
CHB, HBV, hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
VBR 300 mg solution containing 2 µCi [14C]VBR
Intervention Type
Drug
Intervention Name(s)
Vebicorvir (VBR)
Intervention Description
300mg Vebicovir containing 2 µCi [14C]VBR.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Number of Participants with One or More Adverse Events
Time Frame
Up to 168 hours
Title
Number of Participants Discontinued from the Study Due to an Adverse Event
Time Frame
Up to 168 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Consent
Male between 18 and 55 years of age (inclusive) at the time of Screening
Body mass index (BMI) between ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight between ≥55.0 kg and ≤100.0 kg at Screening
Considered to be in good health by the Investigator
Exclusion Criteria:
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
Facility Information:
Facility Name
Pharmaron CPC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate the Mass Balance Absorption and AME of VBR
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