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

January 8, 2021 updated by: Assembly Biosciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pharmaron CPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
VBR 300 mg solution containing 2 µCi [14C]VBR
Drug: Vebicorvir (VBR)
300mg Vebicovir containing 2 µCi [14C]VBR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Before dosing and at prespecified time intervals up to 168 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with One or More Adverse Events
Time Frame: Up to 168 hours
Up to 168 hours
Number of Participants Discontinued from the Study Due to an Adverse Event
Time Frame: Up to 168 hours
Up to 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assembly Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

December 22, 2020

Study Completion (Actual)

December 22, 2020

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI H0731 108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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