Healthy Volunteer StudyPhase 1NCT05004415
Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)
A Phase 1 study testing AT-527 (R07496998) in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Mass balance study of AT-527 in Healthy Male Subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AT-527 (R07496998)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 12 Aug 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Mass balance study of AT-527 in Healthy Male Subjects.
Read the 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.
- Conditions
- Healthy Volunteer Study
- Being tested
- AT-527 (R07496998)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527 (R07496998)Drug
Study participants will receive a single radiolabeled dose of 550 mg AT-527.
| Study group | Role | What they receive |
|---|---|---|
| AT-527 550 mg (R07496998) | Experimental | Not described Receives: Drug: AT-527 (R07496998) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance
Total radioactivity recovery in urine and feces
Measured: Day 1 to Day 15
Mass Balance
Percent of radioactive dose excreted in urine and feces
Measured: Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start28 Jul 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Single-Dose pharmacokinetic (PK) study.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004415
- Sponsor's protocol ID
- AT-03A-006
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No