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