An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

Verified by: AstraZeneca, December 2010
First Received: June 27, 2008 | Last Updated: December 2, 2010 | Phase: Phase 1 | Start Date: July 2008
Overall Status: Completed | Estimated Enrollment: 27
  • …
  • Tell a FriendPrint

The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305...

Brief Summary

Official Title: “A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers”

The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

  • Drug: Ketoconazole
    • Tablet, administered as repeated doses.
  • Drug: Verapamil
    • Extended Release tablet, administered as repeated doses.
  • Drug: AZD1305
    • Extended Release tablet, administered as a single dose.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Ketoconazole tablet + AZD1305 Extended Release tablet
  • Experimental: 2
    • Verapamil Extended Release tablet + AZD1305 Extended Release tablet
  • Experimental: 3
    • AZD1305 Extended Release tablet

Outcome Measures for this Clinical Trial

Primary Measures

  • Pharmacokinetic variables
    • Time Frame: During all dosing visits
      Safety Issue?: No

Secondary Measures

  • Adverse events, vital signs, ECG, laboratory variables and physical examination
    • Time Frame: During the study
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Helen Lunde, MD Study Director AstraZeneca R&D Mölndal, Sweden  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00707551

Study ID Number: D3190C00009

ClinicalTrials.gov Identifier: NCT00707551

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00707551