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

Kowa

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SK-0403

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131091

SK-0403-1.02US

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 5 patient groups

Group A

Other group

Description:

Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment

Treatment:

Drug: SK-0403

Group B

Other group

Description:

Subjects with severe renal impairment

Treatment:

Drug: SK-0403

Group C

Other group

Description:

Subjects with moderate renal impairment

Treatment:

Drug: SK-0403

Group D

Other group

Description:

Subjects with mild renal impairment

Treatment:

Drug: SK-0403

Group E

Other group

Description:

Healthy subjects

Treatment:

Drug: SK-0403