Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

March 5, 2015 updated by: Fuji Yakuhin Co., Ltd.

Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese adult subjects
  • Body mass index: >=18.5 and <30.0

Exclusion Criteria:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderately-decreased group
(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2)
Drug: FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Experimental: Slightly-decreased group
(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2)
Drug: FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Experimental: Normal group
(eGFR: >=90mL/min/1.73m^2)
Drug: FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 48 hours
48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 48 hours
48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame: 48 hours
48 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time Frame: 48 hours
48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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