Healthy
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.
Interventions
Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
DRUGPlacebo, (Oral single dosing)
Subjects randomized to the placebo arm receive placebo.
Sponsors
Fuji Yakuhin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours |
| Pharmacokinetics (kel: Elimination rate constant) | 48 hours |
| Pharmacokinetics (MRT: Mean residence time) | 48 hours |
| Pharmacokinetics (Ae: Amount of drug excreted in urine) | 48 hours |
| Pharmacokinetics (fe: Fraction of dose excreted in urine) | 48 hours |
| Pharmacokinetics (CLr: Renal clearance) | 48 hours |
Countries
Japan
Outcome results
None listed