A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Overview
- Phase
- Phase 1
- Intervention
- SK-0403
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 30
- Primary Endpoint
- The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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
Investigators
Eligibility Criteria
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/m
- •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
Arms & Interventions
Group A
Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment
Intervention: SK-0403
Group B
Subjects with severe renal impairment
Intervention: SK-0403
Group C
Subjects with moderate renal impairment
Intervention: SK-0403
Group D
Subjects with mild renal impairment
Intervention: SK-0403
Group E
Healthy subjects
Intervention: SK-0403
Outcomes
Primary Outcomes
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
Time Frame: 72 Hours
Secondary Outcomes
- 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)