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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01131091
First received: May 25, 2010
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: SK-0403
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131091

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

No publications provided

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
Study First Received: May 25, 2010
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013