Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01103622
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD1656 twice daily Day 1 to Day 7; digoxin on day 4 2 Placebo twice daily Day 1 to Day 7; digoxin on day 4. 1 Digoxin twice daily Day 1 to Day 7; digoxin on day 4 2 Digoxin twice daily Day 1 to Day 7; digoxin on day 4.
- Primary Outcome Measures
Name Time Method 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 Serial PK blood samples will be taken on days 4-8 during the treatment periods
- Secondary Outcome Measures
Name Time Method 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. Safety assessments will be monitored throughout the study, from screening visit until follow up visit. describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2. Serial PK blood samples will be taken on days 4-8 during the treatment periods 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). Serial PK blood samples will be taken on days 4-8 during the treatment periods
Trial Locations
- Locations (1)
Research Site
🇺🇸Chula Vista, California, United States