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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637139
• Other study ID #: ABI H0731 108
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2021
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Vebicorvir (VBR)
300mg Vebicovir containing 2 µCi [14C]VBR.

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants with One or More Adverse Events		Up to 168 hours
Secondary	Number of Participants Discontinued from the Study Due to an Adverse Event		Up to 168 hours