Chronic Hepatitis B
Conditions
Keywords
CHB, HBV, hepatitis B
Brief summary
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of \[14C\] Vebicorvir in healthy male subjects
Interventions
DRUGVebicorvir (VBR)
300mg Vebicovir containing 2 µCi \[14C\]VBR.
Sponsors
Assembly Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Adverse Events | Up to 168 hours |
| Number of Participants Discontinued from the Study Due to an Adverse Event | Up to 168 hours |
Countries
United States
Outcome results
None listed