Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Warfarin (Drug); Placebo (Drug); AZD1656 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Stanko Skrtic, Study Director, Affiliation: AstraZeneca
James Ritter, Prof, Principal Investigator, Affiliation: Quintiles Drug Research Unit
Mirjana Kujacic, Study Chair, Affiliation: AstraZeneca
Overall contact:
Quintiles London, Phone: + 44 0800 634 1132
Summary
The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics
and Pharmacodynamics of Warfarin in T2DM patients.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR).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 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Quintiles London, Phone: + 44 0800 634 1132
Research Site, London, United Kingdom; Recruiting
Additional Information
Starting date: April 2010
Last updated: June 30, 2010
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