Repeated Dose Phase I Study of FYU-981

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FYU-981, (Oral daily dosing for 7 days); Drug: Placebo, (Oral daily dosing for 7 days)

• Registration Number: NCT02348333
• Lead Sponsor: Fuji Yakuhin Co., Ltd.

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-18
• Study First Submitted QC: 2015-01-22
• Last Update Submitted: 2015-01-22
• Study First Posted: 2015-01-28
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
FYU-981	FYU-981, (Oral daily dosing for 7 days)	-
Placebo	Placebo, (Oral daily dosing for 7 days)	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (Cmax: Maximum plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)	1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)	1-, 4-, and 7-day
Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)	4-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)	1-, 4-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)	1-, 4-, and 7-day
Pharmacokinetics (Ae: Amount of drug excreted in urine)	9 days
Pharmacokinetics (fe: Fraction of dose excreted in urine)	9 days

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo, Japan