Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)
- Registration Number
- NCT04849299
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AT-527 550 mg + cyclosporine (staggered) AT-527 550 mg + cyclosporine n=12 AT-527 550 mg + cyclosporine (simultaneous) AT-527 550 mg + cyclosporine n=12
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) of AT-527 (R07496998): AUC Day 1 vs Day 7 Area under the concentration-time curve (AUC)
Pharmacokinetics (PK) of AT-527 (R07496998): Cmax Day 1 vs Day 7 Maximum plasma concentration (Cmax)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇨🇦Montreal, Quebec, Canada