Clinical Pharmacology of FYU-981 (Elder Subjects)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FYU-981, (Oral single dosing)

• Registration Number: NCT02344875
• Lead Sponsor: Fuji Yakuhin Co., Ltd.

Brief Summary

The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-07
• 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: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Japanese adult subjects
• 20-35 Years (non-elder groups)
• 65- Years (elder groups)
• 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
Male non-elder subjects	FYU-981, (Oral single dosing)	Male 20-35 Years
Female non-elder subjects	FYU-981, (Oral single dosing)	Female 20-35 Years
Male elder subjects	FYU-981, (Oral single dosing)	Male 65- Years
Female elder subjects	FYU-981, (Oral single dosing)	Female 65- Years

Primary Outcome Measures

Name	Time	Method
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 (Vd/F: Distribution volume / Fraction of dose absorbed	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

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo, Japan