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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2021-08-12

Brief Summary

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

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Detailed Description

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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

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Healthy Volunteer Study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-Label, Single-Dose pharmacokinetic (PK) study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT-527 550 mg (R07496998)

Group Type EXPERIMENTAL

AT-527 (R07496998)

Intervention Type DRUG

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

Interventions

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AT-527 (R07496998)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes