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Clinical Trials/NCT02348307
NCT02348307CompletedPhase 1

Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

Fuji Yakuhin Co., Ltd.1 site in 1 country54 target enrollmentStarted: March 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Active Comparator

Intervention: FYU-981, (Oral single dosing) (Drug)

Placebo

Placebo Comparator

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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