Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteer Study
- Interventions
- Registration Number
- NCT05905484
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Other clinically significant medical conditions or laboratory abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bemnifosbuvir (BEM) therapeutic dose Bemnifosbuvir (BEM) oral tablets Bemnifosbuvir (BEM) supratherapeutic dose Bemnifosbuvir (BEM) oral tablets Placebo Placebo oral tablets Moxifloxacin Moxifloxacin oral tablet
- Primary Outcome Measures
Name Time Method Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc). 24 hours prior to dosing thru 48 hours post dose C-QTc analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇨🇦Québec, Montreal, Quebec, Canada