NCT05004415

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

February 25, 2022

Status Verified

August 1, 2021

Enrollment Period

15 days

First QC Date

July 27, 2021

Last Update Submit

February 23, 2022

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

AT-527 550 mg (R07496998)

EXPERIMENTAL
Drug: AT-527 (R07496998)

Interventions

AT-527 (R07496998)DRUG

Study participants will receive a single radiolabeled dose of 550 mg AT-527.

AT-527 550 mg (R07496998)

Eligibility Criteria

Age19 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy, adult male, 19-55 years of age, inclusive, at the screening visit.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

AT-511

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-Label, Single-Dose pharmacokinetic (PK) study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 13, 2021

Study Start

July 28, 2021

Primary Completion

August 12, 2021

Study Completion

August 12, 2021

Last Updated

February 25, 2022

Record last verified: 2021-08

Locations

US(1)