Status:
COMPLETED
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
Lead Sponsor:
Toray Industries, Inc
Conditions:
Renal Impairment
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
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 fun...
Eligibility Criteria
Inclusion
- 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
- Patients on dialysis
- Patients who have a history of undergoing renal transplantation
- Patients with diabetes mellitus
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01443429
Start Date
August 1 2011
End Date
February 1 2014
Last Update
March 4 2014
Active Locations (1)
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1
Japan
Japan, Japan