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NCT Number: NCT01103622

Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

Oral tablet bd, step-wise increased dosage

Digoxin

Drug

Oral tablet od on Day 4

Other names: Digacin

Placebo

Drug

Oral tablet bd, step-wise increased dosage

Primary outcomes

  1. 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

    Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods

Secondary outcomes

  1. 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.

    Time frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.

  2. 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).

    Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods

  3. describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.

    Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2010
Registry last updated
Jan 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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