Clincosm LogoSign in Get a demo

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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00713791
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
2
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
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
Study Start Date :
Jun 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Zibotentan

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [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 Outcome Measures

    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 [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. [From time of Consent to Last Visit]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Research Site Philadelphia Pennsylvania United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Sylvan Hurewitz, AZ Clinical Pharmacology Unit, Philadelphia, USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00713791
    Other Study ID Numbers:
    • D4320C00029
    • ZD4054IL0029
    First Posted:
    Jul 11, 2008
    Last Update Posted:
    Nov 15, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    Healthy Volunteers
    ZD4054

    Study Results

    No Results Posted as of Nov 15, 2010