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

NCT ID: NCT04637139

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2020-12-22

Brief Summary

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

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Vebicorvir (VBR)

Intervention Type DRUG

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

Interventions

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Vebicorvir (VBR)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assembly Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pharmaron CPC

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ABI H0731 108

Identifier Type: -

Identifier Source: org_study_id

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