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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.

Criteria

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