ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01131091
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : February 10, 2011
Sponsor:
Information provided by:
Kowa Research Institute, Inc.

Brief 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.)

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: SK-0403 Phase 1

Detailed 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group A
Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment
Drug: SK-0403
SK-0403 400 mg

Group B
Subjects with severe renal impairment
Drug: SK-0403
SK-0403 400 mg

Group C
Subjects with moderate renal impairment
Drug: SK-0403
SK-0403 400 mg

Group D
Subjects with mild renal impairment
Drug: SK-0403
SK-0403 400 mg

Group E
Healthy subjects
Drug: SK-0403
SK-0403 400 mg




Primary Outcome Measures :
  1. The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403. [ Time Frame: 72 Hours ]

Secondary Outcome Measures :
  1. The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency. [ Time Frame: 72 Hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131091


Locations
United States, Florida
Orlando, Florida, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.

Responsible Party: Roger Morgan, MD Chief Medical Officer, Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01131091     History of Changes
Other Study ID Numbers: SK-0403-1.02US
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: February 10, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases