Drug Interaction Study - effect of AZD5672 on the pharmacokinetics of Digoxin

Study identifier:D1710C00021

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label Study to Assess the Effect of AZD5672 at Steady State on the Pharmacokinetics of Digoxin Following Single Dose Administration in Healthy Volunteers

Medical condition

Healthy Volunteers, pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5672, Digoxin

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Jul 2008

Primary Completion Date: 01 Dec 2008

Study Completion Date: 01 Dec 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Berlin, Germany

Arms	Assigned Interventions
Experimental: 1 AZD5672 + Digoxin (single dose on day 12)	Drug: AZD5672 50 mg, for 13 days Drug: Digoxin 0.5mg dose Other Name: Lanoxin
Experimental: 2 AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)	Drug: AZD5672 50 mg, for 13 days Drug: Digoxin 0.5mg dose Other Name: Lanoxin

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1208&filename=CSR-D1710C00021.pdf
Download
CSR-D1710C00021.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Nils Piwon

+49-30-30685-0

nils.piwon@parexel.com

Investigators

Principal Investigator

Rod Hepburn

AstraZeneca R&D, Charnwood, UK