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

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

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

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