Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-18

Study Completion Date

2021-05-10

Brief Summary

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This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects

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Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT-527 550 mg + cyclosporine (simultaneous)

n=12

Group Type EXPERIMENTAL

AT-527 550 mg + cyclosporine

Intervention Type DRUG

550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998

AT-527 550 mg + cyclosporine (staggered)

n=12

Group Type EXPERIMENTAL

AT-527 550 mg + cyclosporine

Intervention Type DRUG

550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998

Interventions

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AT-527 550 mg + cyclosporine

550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998

Intervention Type DRUG

AT-527 550 mg + cyclosporine

550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* 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 SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes