NCT04637139

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

21 days

First QC Date

October 30, 2020

Last Update Submit

January 8, 2021

Conditions

Chronic Hepatitis B

Keywords

CHBHBVhepatitis B

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Group 1

EXPERIMENTAL

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

Drug: Vebicorvir (VBR)

Interventions

Vebicorvir (VBR)DRUG

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

Group 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 19, 2020

Study Start

December 1, 2020

Primary Completion

December 22, 2020

Study Completion

December 22, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

US(1)