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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: AT-527 (R07496998)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT-527 550 mg (R07496998)	Drug: AT-527 (R07496998); Study participants will receive a single radiolabeled dose of 550 mg AT-527.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass Balance	Total radioactivity recovery in urine and feces	Day 1 to Day 15
Mass Balance	Percent of radioactive dose excreted in urine and feces	Day 1 to Day 15

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AT-03A-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No