Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)
- Registration Number
- NCT05137626
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
Drug-drug interaction study of Digoxin and AT-527 (R07496998)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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 18-32 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 + digoxin (staggered) AT-527 + digoxin n=14 AT-527 + digoxin (simultaneous) AT-527 + digoxin n=14
- Primary Outcome Measures
Name Time Method To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin Day 1, Day 15 Area under the concentration-time curve (AUC)
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin Day 1, Day 15 Area under the concentration-time curve (AUC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇨🇦Montreal, Quebec, Canada