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

Study Overview
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: AZD1656
* Drug: Gemfibrozil
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Gemfibrozil