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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD1656; Drug: Gemfibrozil; Drug: Placebo

• Registration Number: NCT01083212
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-30
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1656	Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4
1	Gemfibrozil	Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4
1	Placebo	Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4
2	AZD1656	Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4
2	Placebo	Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4
2	Gemfibrozil	Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Reserach Site; 🇸🇪 Linkoping, Sweden

Research Site; 🇸🇪 Uppsala, Sweden