Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil - Full Text View

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 I

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Gemfibrozil Mitiglinide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

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

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
2: Experimental mitiglinide + gemfibrozil	Drug: gemfibrozil Mitiglinide + 600 mg gemfibrozil bid
1: Placebo Comparator 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

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

Responsible Party:	Elixir Pharmaceuticals ( Paul Martha, Chief Medial Officer )
Study ID Numbers:	EX-1510-CT-002
First Received:	December 3, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00566865
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Gemfibrozil

Metabolic Diseases

Mitiglinide

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Healthy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Elixir Pharmaceuticals
Information provided by:	Elixir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00566865