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
  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

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
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, see Learn About Clinical Studies.

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 September 18, 2014