Healthy Volunteer Study
Conditions
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.
Interventions
DRUGAT-527 (R07496998)
Study participants will receive a single radiolabeled dose of 550 mg AT-527.
Sponsors
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label, Single-Dose pharmacokinetic (PK) study.
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass Balance | Day 1 to Day 15 | Total radioactivity recovery in urine and feces |
Countries
United States
Outcome results
None listed