Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients

November 5, 2010 updated by: AstraZeneca

An Open-Label, Randomised, Placebo-Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics and Pharmacodynamics of Warfarin During Co-administration With AZD1656

The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
  • Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to 270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
  • Haemoglobin (Hb) A1c >6.5% at screening

Exclusion Criteria:

  • Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
  • Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
  • Previous treatment with warfarin on clinical indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
twice daily on Day 1 to Day 10, with Warfarin on Day 4
Drug: Warfarin
Oral tablet od on Day 4
Drug: AZD1656
Oral tablet bd, stepwise increased
Placebo Comparator: 2
twice daily on Day 1 to Day 10, with Warfarin on Day 4
Drug: Warfarin
Oral tablet od on Day 4
Drug: Placebo
Oral tablet bd, stepwise increased

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin).
Time Frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods
Serial PK blood samples will be taken on days 4-10 during the treatment periods

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR).
Time Frame: Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods
Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods
To evaluate the safety of AZD1656 in combination with warfarin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events
Time Frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
To describe the pharmacokinetics of AZD1656 and its metabolite during concomitant warfarin administration by assessment of AUC0-24, Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
Time Frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods
Serial PK blood samples will be taken on days 4-10 during the treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: James Ritter, Prof, Quintiles Drug Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Estimate)

November 7, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1020C00027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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