Skip to main content
OpenTrials
Completed

NCT Number: NCT00709553

Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 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

  • BMI between 18 and 30 kg/m2
  • Medical and surgical history and physical examination without any clinically significant findings
  • Normal resting ECG with QTcB interval <450ms

Exclusion criteria

  • Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
  • Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
  • Medical diagnosis of migraine with an attack during the 12 months prior to Screening

Treatment and study plan

midazolam

Drug

Other names: Dormicum®

ZD4054

Drug

ZD4054 10 mg od

Other names: Zibotentan

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during study

Secondary outcomes

  1. Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in Healthy Male Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2008
Registry last updated
Sep 28, 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.