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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD9742 | Drug: AZD9742 Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole Drug: Diltiazem Orally, daily beginning on Day 4 for 14 consecutive days Other Name: Myoderm Drug: ketoconazole 200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered |
Contacts
Investigators
Principal Investigator
Ralph Schutz
Quintiles
