Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil | NCT00566865

Studies
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

NCT00566865

Sponsor

Elixir Pharmaceuticals

Status

Completed

Last Update Posted

Feb 18, 2009Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

placebo for gemfibrozil
gemfibrozil

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental	mitiglinide + gemfibrozil	Drug: gemfibrozil
1	Placebo Comparator	mitiglinide + placebo for gemfibrozil	Drug: placebo for gemfibrozil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo for gemfibrozil	Drug	mitiglinide + placebo for gemfibrozil 600 mg bid	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erin Nulf, RN, BSN	Quintiles Phase I Services	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015248	Gemfibrozil

Ancestor Terms

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided