NCT00712465

Brief Summary

The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 atrial-fibrillation

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1 atrial-fibrillation

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

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

July 8, 2008

Last Update Submit

December 2, 2010

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationinteractionpharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables

    During all dosing visits

Secondary Outcomes (1)

  • Adverse event, vital signs, ECG, physical examination and laboratory variables.

    During the study

Study Arms (3)

1

EXPERIMENTAL

AZD1305 tablet

Drug: AZD1305

2

EXPERIMENTAL

AZD1305 tablet + digoxin

Drug: AZD1305Drug: Digoxin

3

ACTIVE COMPARATOR

Digoxin

Drug: Digoxin

Interventions

AZD1305DRUG

Extended Release tablet, repeated administration

12
DigoxinDRUG

Tablet, repeated administration

23

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

You may not qualify if:

  • Potassium outside normal reference values
  • ECG findings outside normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamateDigoxin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Helen Lunde, MD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Marianne Hartford, MD, PhD

    AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

SE(1)