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OpenTrials
Completed

NCT Number: NCT04637139

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

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

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Vebicorvir (VBR)

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Number of Participants with One or More Adverse Events

    Time frame: Up to 168 hours

  2. Number of Participants Discontinued from the Study Due to an Adverse Event

    Time frame: Up to 168 hours

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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