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Completed

NCT Number: NCT01443429

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Japan

Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

beraprost sodium(BPS)

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2011
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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