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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Drug: AT-527 + rosuvastatin; Drug: AT-527 + rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05154123

AT-03A-012

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

AT-527 + rosuvastatin (simultaneous) n=14

Experimental group

Treatment:

Drug: Drug: AT-527 + rosuvastatin

AT-527 + rosuvastatin (staggered) n=14

Experimental group

Treatment:

Drug: AT-527 + rosuvastatin