FOY-305-03:FOY-305 TQT study(COVID-19)
Phase 1
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2071200109
- Lead Sponsor
- Osawa Masahiro
- Brief Summary
When the dose of FOY-305 was 600 mg, which is feasible and expected to lead to its maximum exposure in the plasma, PK parameter values of plasma FOY-251 were similar to those in FOY-305-02 study. Additionally, this study provided the information of plasma exposure that enables proper evaluation of QTc. A single dose of FOY-305 600 mg under fasted condition showed no significant impact on QTc. FOY-305 treatment had no safety concerns and was well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 39
Inclusion Criteria
Japanese healthy adult male, >=18 and <=45 of age, >=18.5 and <25.0 of BMI
Exclusion Criteria
Medical history of severe disease, severe allergy for foods and drugs, QTcF>=450ms at SCR
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prolongation of QT/QTc interval
- Secondary Outcome Measures
Name Time Method