An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ketoconazole; Drug: Verapamil; Drug: AZD1305

• Registration Number: NCT00707551
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study Start: 2008-07
• Study First Posted: 2008-07-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Ketoconazole	Ketoconazole tablet + AZD1305 Extended Release tablet
1	AZD1305	Ketoconazole tablet + AZD1305 Extended Release tablet
2	AZD1305	Verapamil Extended Release tablet + AZD1305 Extended Release tablet
3	AZD1305	AZD1305 Extended Release tablet
2	Verapamil	Verapamil Extended Release tablet + AZD1305 Extended Release tablet

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During all dosing visits

Secondary Outcome Measures

Name	Time	Method
Adverse events, vital signs, ECG, laboratory variables and physical examination	During the study

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany