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

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Vebicorvir (VBR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04637139

ABI H0731 108

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Group 1

Experimental group

Description:

VBR 300 mg solution containing 2 µCi \[14C\]VBR

Treatment:

Drug: Vebicorvir (VBR)