Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

AZD1656

Gemfibrozil

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Gemfibrozil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Reserach Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.

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

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

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

Full Information

NCT ID

NCT01083212

First Posted

March 8, 2010

Last Updated

June 30, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01083212

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Gemfibrozil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AZD1656

Intervention Description

Single dose,oral tablet

Intervention Type

Drug

Intervention Name(s)

Gemfibrozil

Intervention Description

Oral tablet bid on day 1 - 5.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablet bid on day 1-5

Primary Outcome Measure Information:

Title

PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.

Time Frame

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 Measure Information:

Title

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

Time Frame

Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.

Title

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

Time Frame

Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.

Title

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: