Clinical Pharmacology of FYU-981 (Final Formulation)
- Registration Number
- NCT03350373
- Lead Sponsor
- Mochida Pharmaceutical Company, Ltd.
- Brief Summary
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Japanese healthy adult subjects
- Body mass index: >=18.5 and <25.0
Exclusion Criteria
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fasted dosing followed by fed dosing FYU-981 Dosing of FYU-981 in the fasted state followed by fed dosing Fed dosing followed by fasted dosing FYU-981 Dosing of FYU-981 in the fed state followed by fasted dosing
- Primary Outcome Measures
Name Time Method Pharmacokinetics (Cmax: Maximum plasma concentration) 48 hours Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed) 48 hours Pharmacokinetics (MRT: Mean residence time) 48 hours Safety (Incidence of treatment-emergent adverse events) 13 days Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) 48 hours Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed) 48 hours Pharmacokinetics (kel: Elimination rate constant) 48 hours Pharmacokinetics 48 hours T1/2: Elimination half-life of plasma concentration
Pharmacokinetics (AUC: Area under the plasma concentration-time curve) 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
P-One Clinic
🇯🇵Hachiōji, Tokyo, Japan