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Completed

NCT Number: NCT05004415

Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)

Mass balance study of AT-527 in Healthy Male Subjects.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Lincoln, Nebraska, 68502, United States

About this study

This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and mass balance of [14C]-AT-527 in healthy adult male subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
  • No clinically significant diseases captured in the medical history or clinically significant findings at screening physical examination.
  • A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male).
  • Willing to comply with the study requirements and to provide written informed consent

Exclusion criteria

  • Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
  • Abuse of alcohol or drugs
  • Use of other investigational drugs within 28 days of dosing
  • Other clinically significant medical conditions or laboratory abnormalities

Treatment and study plan

AT-527 (R07496998)

Drug

Study participants will receive a single radiolabeled dose of 550 mg AT-527.

Primary outcomes

  1. Mass Balance

    Time frame: Day 1 to Day 15

    Total radioactivity recovery in urine and feces

  2. Mass Balance

    Time frame: Day 1 to Day 15

    Percent of radioactive dose excreted in urine and feces

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-AT-527 in Healthy Adult Male Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Feb 25, 2022

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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