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

Toray Industries, Inc24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

beraprost sodium(BPS)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Japan

Japan, Japan

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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