NCT00723424

Brief Summary

The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 2, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

July 24, 2008

Last Update Submit

November 30, 2010

Conditions

Healthy VolunteersPharmacokinetics

Keywords

AZD5672digoxin

Outcome Measures

Primary Outcomes (1)

  • PK variables

    Frequent sampling occasions during study periods

Secondary Outcomes (1)

  • Safety variables (adverse events, blood pressure, pulse, safety lab)

    During the whole treatment periods

Study Arms (2)

1

EXPERIMENTAL

AZD5672 + Digoxin (single dose on day 12)

Drug: AZD5672Drug: Digoxin

2

EXPERIMENTAL

AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)

Drug: AZD5672Drug: Digoxin

Interventions

AZD5672DRUG

50 mg, for 13 days

12
DigoxinDRUG

0.5mg dose

Also known as: Lanoxin
12

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed written informed consent.
  • Females should not be of childbearing potential
  • Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV.

You may not qualify if:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
  • Known allergy to digoxin or previous complications to digoxin therapy.
  • Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Berlin, Germany

Location

MeSH Terms

Interventions

N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamideDigoxin

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Rod Hepburn

    AstraZeneca R&D, Charnwood, UK

    STUDY DIRECTOR

  • Rainard Fuhr

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 2, 2010

Record last verified: 2010-11

Locations

DE(1)