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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00713791
First received: July 9, 2008
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ZD4054
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2008
Study Completion Date: August 2008
Arms Assigned Interventions
Experimental: 1
There are 5 variations of the ZD4054 (Zibotentan) 10mg tablet - A, B, C, D, and E. A minimum washout period of 1 week will occur between each treatment period.
Drug: ZD4054
Treatment period 1: 10mg oral solution
Other Name: Zibotentan
Drug: ZD4054
Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Other Name: Zibotentan
Drug: ZD4054
Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Other Name: Zibotentan
Drug: ZD4054
Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Other Name: Zibotentan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713791

Locations
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Sylvan Hurewitz AZ Clinical Pharmacology Unit, Philadelphia, USA
  More Information

No publications provided

Responsible Party: Dr Thomas Morris, Medical Science Director, AstraZeneca, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00713791     History of Changes
Other Study ID Numbers: D4320C00029, ZD4054IL0029
Study First Received: July 9, 2008
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Healthy Volunteers
ZD4054

ClinicalTrials.gov processed this record on August 26, 2014