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

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01131091

Run by

Kowa Research Institute, Inc.

People needed

30

Starts

2010-05-01

Expected to finish

2010-11-01

Last updated by the study team

2011-02-10

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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