NCT01443429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2.5 years

First QC Date

September 25, 2011

Last Update Submit

March 3, 2014

Conditions

Renal Impairment

Keywords

TRK-100STPPKberaprost sodiumJapanese males and femalesSubjects with mild/moderate/severe patientsrenal impairment

Outcome Measures

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)

    Up to 48hr

Study Arms (4)

subjects with normal renal function

EXPERIMENTAL
Drug: beraprost sodium(BPS)

patients with mild renal impairment

EXPERIMENTAL
Drug: beraprost sodium(BPS)

patients with moderate renal impairment

EXPERIMENTAL
Drug: beraprost sodium(BPS)

patients with severe renal impairment

EXPERIMENTAL
Drug: beraprost sodium(BPS)

Interventions

beraprost sodium(BPS)DRUG
patients with mild renal impairmentpatients with moderate renal impairmentpatients with severe renal impairmentsubjects with normal renal function

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients on dialysis
  • Patients who have a history of undergoing renal transplantation
  • Patients with diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Japan, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

beraprost

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 29, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

JP(1)