A Study to Evaluate the Mass Balance Absorption and AME of VBR
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: Vebicorvir (VBR)
- Registration Number
- NCT04637139
- Lead Sponsor
- Assembly Biosciences
- Brief Summary
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of \[14C\] Vebicorvir in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 Vebicorvir (VBR) VBR 300 mg solution containing 2 µCi \[14C\]VBR
- Primary Outcome Measures
Name Time Method Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C) 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) Before dosing and at prespecified time intervals up to 168 hours after dosing
- Secondary Outcome Measures
Name Time Method Number of Participants Discontinued from the Study Due to an Adverse Event Up to 168 hours Number of Participants with One or More Adverse Events Up to 168 hours
Trial Locations
- Locations (1)
Pharmaron CPC
🇺🇸Baltimore, Maryland, United States