Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)

Phase 1CompletedNCT04849299

Atea Pharmaceuticals, Inc.24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

AT-527 550 mg + cyclosporineDRUG

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 + cyclosporineDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Atea Study Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of AT-527 (R07496998): Cmax

Maximum plasma concentration (Cmax)

Time frame: Day 1 vs Day 7

Pharmacokinetics (PK) of AT-527 (R07496998): AUC

Area under the concentration-time curve (AUC)

Time frame: Day 1 vs Day 7

Data from ClinicalTrials.gov

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