Open label study, assessing the effect of Diltiazem or Ketoconazole on the pharmacokinetics of AZD9742 in healthy volunteers

Study identifier:D2690C00008

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Single Center, Open Label, 2-consecutive-group, 2-period, 1-sequence Crossover Study to Assess the Effect of Diltiazem (Cardizem), a Moderate CYP3A4 Inhibitor, or Ketoconazole, a Potent CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Intravenous Dose of 150mg of AZD9742.

Medical condition

pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9742, Diltiazem, ketoconazole

Sex

All

Actual enrollment

28

Study type

Interventional

Age

23 Years - 45 Years

Date

Study Start Date: 01 May 2010
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria