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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01103622

First received: April 13, 2010

Last updated: January 4, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 13, 2010

Last Updated Date

January 4, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01103622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: AZD1656
Oral tablet bd, step-wise increased dosage
Drug: Digoxin
Oral tablet od on Day 4

Other Name: Digacin
Drug: Placebo
Oral tablet bd, step-wise increased dosage

Study Arm (s)

Experimental: 1
twice daily Day 1 to Day 7; digoxin on day 4
Interventions:
- Drug: AZD1656
- Drug: Digoxin
Placebo Comparator: 2
twice daily Day 1 to Day 7; digoxin on day 4.
Interventions:
- Drug: Digoxin
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01103622

Other Study ID Numbers ^ICMJE

D1020C00031

Has Data Monitoring Committee

Not Provided

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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