Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)

Phase 1CompletedNCT05154123

Atea Pharmaceuticals, Inc.29 enrolled

Overview

Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

Drug: AT-527 + rosuvastatinDRUG

* Day 1: A single dose of rosuvastatin will be administered. * Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.

AT-527 + rosuvastatinDRUG

* Day 1: A single dose of rosuvastatin will be administered. * Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later)

Eligibility

Sex: ALLMin 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 * Females must have a negative pregnancy test at Screening and prior to dosing * 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

Québec, Montreal, Quebec, Canada

Outcomes

Primary Outcomes

To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin

Maximum plasma concentration (Cmax)

Time frame: Day 1, Day 8

To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin

Area under the concentration-time curve (AUC)

Time frame: Day 1, Day 8

To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin

Area under the concentration-time curve (AUC)

Time frame: Day 1, Day 8

To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin

Maximum plasma concentration (Cmax)

Time frame: Day 1, Day 8

Data from ClinicalTrials.gov

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