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

Toray Industries

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: beraprost sodium(BPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01443429

100CRS03

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 4 patient groups

subjects with normal renal function

Experimental group

Treatment:

Drug: beraprost sodium(BPS)

patients with mild renal impairment

Experimental group

Treatment:

Drug: beraprost sodium(BPS)

patients with moderate renal impairment

Experimental group

Treatment:

Drug: beraprost sodium(BPS)

patients with severe renal impairment

Experimental group

Treatment:

Drug: beraprost sodium(BPS)