A Phase 1 Drug-drug Interaction Study of Ensitrelvir with Itraconazole or Carbamazepine in Healthy Adult Participants
Phase 1
Recruiting
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2071230049
- Lead Sponsor
- Gomez Juan Carlos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Japanese healthy adult male and female participants
Exclusion Criteria
Past or current medical history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Ensitrelvir: Cmax, Tmax, AUC0-tau, C24 <br>-Itraconazole: Cmax, Tmax, AUC0-tau<br>-Carbamazepine: Cmax, Tmax, AUC0-tau<br>-Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG
- Secondary Outcome Measures
Name Time Method