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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443429
• Other study ID #: 100CRS03
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2011
• Last updated: March 3, 2014
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• beraprost sodium(BPS)

Locations

Country	Name	City	State
Japan	Japan	Japan

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 48hr	Yes