A Study to Evaluate the Mass Balance Absorption and AME of VBR

Assembly Biosciences6 enrolled

Overview

This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of \[14C\] Vebicorvir in healthy male subjects

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

Vebicorvir (VBR)DRUG

300mg Vebicovir containing 2 µCi \[14C\]VBR.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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

Locations (1)

Pharmaron CPC

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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