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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: AT-527 (R07496998)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05004415

AT-03A-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

AT-527 550 mg (R07496998)

Experimental group

Treatment:

Drug: AT-527 (R07496998)