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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131091
• Other study ID #: SK-0403-1.02US
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2010
• Last updated: February 9, 2011
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SK-0403
SK-0403 400 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes