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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01443429
Enrollment
24
Registered
2011-09-29
Start date
2011-08-31
Completion date
2014-02-28
Last updated
2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

TRK-100STP, PK, beraprost sodium, Japanese males and females, Subjects with mild/moderate/severe patients, renal impairment

Brief 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.

Interventions

DRUGberaprost sodium(BPS)

Sponsors

Toray Industries, Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026