Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Fuji Yakuhin Co., Ltd.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (Cmax: Maximum plasma concentration)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
FYU-981
Intervention: FYU-981, (Oral single dosing) (Drug)
Placebo
Intervention: Placebo, (Oral single dosing) (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time Frame: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time Frame: 48 hours
Pharmacokinetics (CLr: Renal clearance)
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported