Expired Study
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Philadelphia, Pennsylvania


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.


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


Study is Available At:


Original ID:

D4320C00029


NCT ID:

NCT00713791


Secondary ID:

ZD4054IL0029


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:June 2008
Completion Date:August 2008
Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 10, 2010
First Received Date:July 9, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ZD4054
Description:Treatment period 1: 10mg oral solution
Arm Name:1
Other Name:Zibotentan
Intervention Type:Drug
Name:ZD4054
Description:Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Arm Name:1
Other Name:Zibotentan
Intervention Type:Drug
Name:ZD4054
Description:Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Arm Name:1
Other Name:Zibotentan
Intervention Type:Drug
Name:ZD4054
Description:Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Arm Name:1
Other Name:Zibotentan

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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