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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01103622
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
6
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

twice daily Day 1 to Day 7; digoxin on day 4

Drug: AZD1656
Oral tablet bd, step-wise increased dosage

Drug: Digoxin
Oral tablet od on Day 4
Other Names:
  • Digacin

    		•
    Placebo Comparator: 2

    twice daily Day 1 to Day 7; digoxin on day 4.

    Drug: Digoxin
    Oral tablet od on Day 4
    Other Names:
  • Digacin

    • Drug: Placebo
    Oral tablet bd, step-wise increased dosage

    Outcome Measures

    Primary Outcome Measures

    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 [Serial PK blood samples will be taken on days 4-8 during the treatment periods]

    Secondary Outcome Measures

    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. [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). [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. [Serial PK blood samples will be taken on days 4-8 during the treatment periods]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Chula Vista California United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Stanko Skrtic, AstraZeneca
    • Principal Investigator: Christoph Kapitza, Profil Institut für Stoffwechselforschung GmbH
    • Study Chair: Mirjana Kujacic, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01103622
    Other Study ID Numbers:
    • D1020C00031
    First Posted:
    Apr 14, 2010
    Last Update Posted:
    Jan 5, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    Diabetes
    Type 2
    Digoxin
    drug-drug interaction
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Digoxin

    Study Results

    No Results Posted as of Jan 5, 2011