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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131091

Enrollment

Registered

2010-05-26

Start date

2010-05-31

Completion date

2010-11-30

Last updated

2011-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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

Interventions

DRUGSK-0403

SK-0403 400 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026