Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: gemfibrozil; Drug: placebo for gemfibrozil

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pharmacokinetics of mitiglinide	3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide	3 days of treatment with gemfibrozil

Secondary Outcome Measures

Outcome Measure	Time Frame
safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil	3 days of treatment with gemfibrozil

Collaborators and Investigators

• Sponsor: Elixir Pharmaceuticals
• Investigators: Study Director: Erin Nulf, RN, BSN, Quintiles Phase I Services

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimate): December 4, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2009
• Last Update Submitted That Met QC Criteria: February 16, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP2C8 Inhibitors; Gemfibrozil
• Other Study ID Numbers: EX-1510-CT-002