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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Gemfibrozil; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT01083212

D1020C00030

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Gemfibrozil

Drug: AZD1656

Drug: Placebo

2

Experimental group

Description:

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

Treatment:

Drug: Gemfibrozil

Drug: AZD1656

Drug: Placebo