A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
- Registration Number
- NCT01131091
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)
- Detailed Description
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:
Group A: Subjects with ESRD who are receiving hemodialysis treatment
Group B: Subjects with severe renal impairment
Group C: Subjects with moderate renal impairment
Group D: Subjects with mild renal impairment
Group E: Healthy subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Subject is an adult male or female aged 18 to 79 years, inclusive.
- All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level >35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is able and willing to comply with the protocol and study procedures.
Exclusion Criteria
- Subject has a BMI >37 kg/m2.
- Subject has taken any prescribed systemic or topical medication
- Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
- Subject has received an investigational drug within 30 days before dosing.
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
- Subject has had a clinically significant illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group E SK-0403 Healthy subjects Group A SK-0403 Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment Group B SK-0403 Subjects with severe renal impairment Group C SK-0403 Subjects with moderate renal impairment Group D SK-0403 Subjects with mild renal impairment
- Primary Outcome Measures
Name Time Method The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403. 72 Hours
- Secondary Outcome Measures
Name Time Method The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency. 72 Hours