Skip to main content
OpenTrials
Completed

NCT Number: NCT00707551

An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoconazole

Drug

Tablet, administered as repeated doses.

Other names: Fungoral

Verapamil

Drug

Extended Release tablet, administered as repeated doses.

Other names: Isoptin Retard

AZD1305

Drug

Extended Release tablet, administered as a single dose.

Primary outcomes

  1. Pharmacokinetic variables

    Time frame: During all dosing visits

Secondary outcomes

  1. Adverse events, vital signs, ECG, laboratory variables and physical examination

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 1, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.