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...
Date First Received: June 27, 2008
Last Updated: September 3, 2008
Verified by: AstraZeneca, September 2008
Clinical Trial Phase: Phase 1 | Start Date: July 2008
Overall Status: Recruiting
Estimated Enrollment: 27
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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
- Time Frame: During all dosing visits
Secondary Measures
- Adverse events, vital signs, ECG, laboratory variables and physical examination
- Time Frame: During the study
Safety Issue?: Yes
- Time Frame: During the study
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 Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Helen Lunde, MD Study Director AstraZeneca R&D Mölndal, Sweden
Overall Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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
Clinical Trials Authorship and Review
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