An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Ketoconazole (Drug); Verapamil (Drug); AZD1305 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Helen Lunde, MD, Study Director, Affiliation: AstraZeneca R&D Mölndal, Sweden
Dago Mazur, MD, PhD, Principal Investigator, Affiliation: PAREXEL International GmbH, Berlin, Germany
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic variables
Secondary outcome: Adverse events, vital signs, ECG, laboratory variables and physical examination
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Berlin, Germany; Recruiting
Additional Information
Starting date: July 2008
Ending date: December 2008
Last updated: July 7, 2008
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