Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

This study has been completed.
Sponsor:
Information provided by:
Elixir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00566865
First received: December 3, 2007
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: placebo for gemfibrozil
Drug: gemfibrozil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Elixir Pharmaceuticals:

Primary Outcome Measures:
  • pharmacokinetics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ] [ Designated as safety issue: No ]
  • pharmacodynamics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil [ Time Frame: 3 days of treatment with gemfibrozil ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
mitiglinide + gemfibrozil
Drug: gemfibrozil
Mitiglinide + 600 mg gemfibrozil bid
Placebo Comparator: 1
mitiglinide + placebo for gemfibrozil
Drug: placebo for gemfibrozil
mitiglinide + placebo for gemfibrozil 600 mg bid

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-smoker
  • Body mass index (BMI) of 19-28 kg/m2
  • no relevant food allergies

Exclusion Criteria:

  • any subject for whom gemfibrozil is contraindicated
  • any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
  • clinically significant history of or current abnormality or disease of any organ system
  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: NCT00566865

Sponsors and Collaborators
Elixir Pharmaceuticals
Investigators
Study Director: Erin Nulf, RN, BSN Quintiles Phase I Services
  More Information

No publications provided

Responsible Party: Paul Martha, Chief Medial Officer, Elixir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00566865     History of Changes
Other Study ID Numbers: EX-1510-CT-002
Study First Received: December 3, 2007
Last Updated: February 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Gemfibrozil
Mitiglinide
Antimetabolites
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014