Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)
- Registration Number
- NCT05004415
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
Mass balance study of AT-527 in Healthy Male Subjects.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AT-527 550 mg (R07496998) AT-527 (R07496998) -
- Primary Outcome Measures
Name Time Method Mass Balance Day 1 to Day 15 Percent of radioactive dose excreted in urine and feces
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇺🇸Lincoln, Nebraska, United States