To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

NCT ID: NCT01083212

Last Updated: 2010-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Single dose,oral tablet

Gemfibrozil

Intervention Type DRUG

Oral tablet bid on day 1 - 5.

Placebo

Intervention Type DRUG

Oral tablet bid on day 1-5

2

Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Single dose,oral tablet

Gemfibrozil

Intervention Type DRUG

Oral tablet bid on day 1 - 5.

Placebo

Intervention Type DRUG

Oral tablet bid on day 1-5

Interventions

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AZD1656

Single dose,oral tablet

Intervention Type DRUG

Gemfibrozil

Oral tablet bid on day 1 - 5.

Intervention Type DRUG

Placebo

Oral tablet bid on day 1-5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria

* Intake of another investigational drug within the last 30 days prior to enrolment.
* Clinically significant illness or clinically relevant trauma.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Stanko Skrtic

Role: STUDY_DIRECTOR

AstraZeneca

Aslak Rautio

Role: PRINCIPAL_INVESTIGATOR

Quintiles Hermelinen AB

Wolfgang Kuhn

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB

Folke Sjöberg

Role: PRINCIPAL_INVESTIGATOR

J.J. Berzelius Clinical Research Center AB

Mirjana Kujacic

Role: STUDY_CHAIR

AstraZeneca

Locations

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Reserach Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D1020C00030

Identifier Type: -

Identifier Source: org_study_id

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