Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus 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: AZD1656 (Drug); Digoxin (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Stanko Skrtic, Study Director, Affiliation: AstraZeneca
Christoph Kapitza, Principal Investigator, Affiliation: Profil Institut für Stoffwechselforschung GmbH
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
(PK) of digoxin in type 2 diabetes mellitus (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 of Digoxin During Co-administration With AZD1656
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Secondary outcome: evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only). describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with confirmed type 2 diabetes for at least 1 year and treated with
metformin as a single treatment or in combination with one other oral anti diabetic
for at least 2 months prior to screening.
- Body mass index between ≥19 and ≤42 kg/m2.
- Haemoglobin (Hb) A1c ≥6. 5% and ≤9. 5% at enrolment.
Exclusion Criteria:
- History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled
hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
- Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
- Use of amiodarone within 3 months prior to screening and the use of potent CYP450
inhibitors
Locations and Contacts
Quintiles London, Phone: + 44 0800 634 1132
Research Site, Chula Vista, California, United States; Recruiting
Additional Information
Starting date: June 2010
Last updated: September 27, 2010
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