A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
- Registration Number
- NCT01443429
- Lead Sponsor
- Toray Industries, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description subjects with normal renal function beraprost sodium(BPS) - patients with mild renal impairment beraprost sodium(BPS) - patients with moderate renal impairment beraprost sodium(BPS) - patients with severe renal impairment beraprost sodium(BPS) -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
🇯🇵Japan, Japan