Skip to main content
OpenTrials
Completed

NCT Number: NCT00713791

Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.

This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

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

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normal resting 12-lead ECG with normal QTc interval (<450 msec)
  • Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion criteria

  • Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
  • Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
  • Judgement by the investigator, that the healthy volunteer should not participate in the study

Treatment and study plan

ZD4054

Drug

Treatment period 1: 10mg oral solution

Other names: Zibotentan

Primary outcomes

  1. characterise and compare the plasma concentration-time profiles for ZD4054 (Zibotentan) when administered as reference oral solution formulation and as 5 solid oral formulations.

    Time frame: 00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs

Secondary outcomes

  1. characterise and compare pharmacokinetic parameters for ZD4054 (Zibotentan) when administered as an oral solution and as 5 solid oral formulations and to assure the safety of all healthy volunteers by assessment of vital signs, ECG, Labs, and AEs

    Time frame: 00.05, 00.10, 00.15, 00.20, 00.30, 00.40, 00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs

  2. To assure the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.

    Time frame: From time of Consent to Last Visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Single-blind, Single-centre, Incomplete-block Crossover, Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets

Important dates

Study start
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Nov 15, 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.