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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: AT-527 550 mg + cyclosporine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04849299

AT-03A-005

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

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
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

AT-527 550 mg + cyclosporine (simultaneous)

Experimental group

Description:

n=12

Treatment:

Drug: AT-527 550 mg + cyclosporine

Drug: AT-527 550 mg + cyclosporine

AT-527 550 mg + cyclosporine (staggered)

Experimental group

Description:

n=12

Treatment:

Drug: AT-527 550 mg + cyclosporine

Drug: AT-527 550 mg + cyclosporine