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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01083212

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: AZD1656 Drug: Gemfibrozil Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomised, Open, Placebo Controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4	Drug: AZD1656 Single dose,oral tablet Drug: Gemfibrozil Oral tablet bid on day 1 - 5. Drug: Placebo Oral tablet bid on day 1-5
Experimental: 2 Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4	Drug: AZD1656 Single dose,oral tablet Drug: Gemfibrozil Oral tablet bid on day 1 - 5. Drug: Placebo Oral tablet bid on day 1-5

Arm

Intervention/Treatment

Experimental: 1

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

Drug: AZD1656

Single dose,oral tablet

Drug: Gemfibrozil

Oral tablet bid on day 1 - 5.

Drug: Placebo

Oral tablet bid on day 1-5

Experimental: 2

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

Drug: AZD1656

Single dose,oral tablet

Drug: Gemfibrozil

Oral tablet bid on day 1 - 5.

Drug: Placebo

Oral tablet bid on day 1-5

Outcome Measures

Primary Outcome Measures

PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax. [Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.]

Secondary Outcome Measures

PK of AZD1656 when administered with placebo or following repeated dosing of germfibrozil by assessment of AUC0-t, tmax, t1/2, CL/F and Vz/F [Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.]
PK of AZD1656 metabolite, when AZD1656 is administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC, AUC0-t, Cmax, tmax, t1/2 [Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.]
Safety of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables including 24-h plasma glucose, physical examination and adverse events [Paper ECG, BP/pulse preentry, pre-dose,day 4, period 1 and 2, and follow-up on day +7-10 days. Weight, physical examination preentry and pre-dose (period 1 and 2), follow-up. 7-point plasma-glucose on pre-entry, day 3 and 5, period 1 and 2.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Reserach Site	Linkoping	Sweden
2	Research Site	Lulea	Sweden
3	Research Site	Uppsala	Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Stanko Skrtic, AstraZeneca
Principal Investigator: Aslak Rautio, Quintiles Hermelinen AB
Principal Investigator: Wolfgang Kuhn, Quintiles AB
Principal Investigator: Folke Sjöberg, J.J. Berzelius Clinical Research Center AB
Study Chair: Mirjana Kujacic, AstraZeneca