Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Toray Industries, Inc
Treatments:
Beraprost
Epoprostenol
Criteria
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