Loading clinical trials...
Loading clinical trials...
A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)
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
Age
18 - 79 years
Sex
ALL
Healthy Volunteers
Yes
Orlando, Florida, United States
Minneapolis, Minnesota, United States
Start Date
May 1, 2010
Primary Completion Date
November 1, 2010
Completion Date
November 1, 2010
Last Updated
February 10, 2011
30
ESTIMATED participants
SK-0403
DRUG
Lead Sponsor
Kowa Research Institute, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07433062