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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ZD4054
* Drug: ZD4054
* Drug: ZD4054
* Drug: ZD4054


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Treatment period 1: 10mg oral solution<br>* Other names: Zibotentan;Drug: ZD4054<br>* Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.<br>* Other names: Zibotentan;Drug: ZD4054<br>* Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.<br>* Other names: Zibotentan;Drug: ZD4054<br>* Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.<br>* Other names: Zibotentan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, ZD4054