KRP-AM1977X QT/QTc study
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222958
- Lead Sponsor
- Kyorin Pharmaceutical Co., Ltd.
- Brief Summary
AM-1977 was evaluated for QT/QTc prolongation in single oral doses of 225 mg, 450 mg and 750 mg, with the 225 mg dose being negative and the 450 mg dose being positive. There was a positive correlation between AM-1977 plasma concentration and Double-Delta QTcF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
Japanese healthy adult male
- Person with BMI that is more than 18.5 but less than 25.0, etc.
Exclusion Criteria
Healthy male subject with an inadequate medical history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>other<br>QTcF<br>ECG
- Secondary Outcome Measures
Name Time Method safety<br>other<br>QTcB ,etc.<br>ECG ,etc.