A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment

March 3, 2014 updated by: Toray Industries, Inc

A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese Patients With Renal Impairment as Compared to Subjects With Normal Renal Function

The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
      • Japan, 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

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The eGFR 1 day before study drug administration are stipulated as follows.
  • Subjects with normal renal function : ≥90
  • Patients with mild renal impairment : ≥60 to <90
  • Patients with moderate renal impairment : ≥30 to <60
  • Patients with severe renal impairment : ≥15 to <30

Exclusion Criteria:

  • Patients on dialysis
  • Patients who have a history of undergoing renal transplantation
  • Patients with diabetes mellitus

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subjects with normal renal function
Drug: beraprost sodium(BPS)
Experimental: patients with mild renal impairment
Drug: beraprost sodium(BPS)
Experimental: patients with moderate renal impairment
Drug: beraprost sodium(BPS)
Experimental: patients with severe renal impairment
Drug: beraprost sodium(BPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax,pg/mL), area under the plasma concentration-time curve (AUC,pg·hr/mL), time at maximum concentration (Tmax,hr) and mean residence time (MRT,hr)
Time Frame: Up to 48hr
Up to 48hr

Collaborators and Investigators

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

Sponsor

Toray Industries, Inc

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

August 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 25, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100CRS03

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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