NCT01131091

A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SK-0403	SK-0403 400 mg

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-05-26
• Last updated: 2011-02-10

Locations

2 sites across 1 country: United States