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

Healthy Volunteer Study Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004415
• Other study ID #: AT-03A-006
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: August 2021
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• AT-527 (R07496998)
Study participants will receive a single radiolabeled dose of 550 mg AT-527.

Locations

Country	Name	City	State
United States	Atea Study Site	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass Balance	Total radioactivity recovery in urine and feces	Day 1 to Day 15
Primary	Mass Balance	Percent of radioactive dose excreted in urine and feces	Day 1 to Day 15