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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: SK-0403


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment | Drug: SK-0403<br>* SK-0403 400 mg<br>|
| Other: Group B<br>Subjects with severe renal impairment | Drug: SK-0403<br>* SK-0403 400 mg<br>|
| Other: Group C<br>Subjects with moderate renal impairment | Drug: SK-0403<br>* SK-0403 400 mg<br>|
| Other: Group D<br>Subjects with mild renal impairment | Drug: SK-0403<br>* SK-0403 400 mg<br>|
| Other: Group E<br>Healthy subjects | Drug: SK-0403<br>* SK-0403 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |