Relative Bioavailability of Phase II and Phase III Formulations of AZD0530 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00771979

Purpose

The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Condition	Intervention	Phase
Healthy	Drug: AZD0530	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title:	A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To monitor 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 ]
An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD0530 of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order. Drug: AZD0530 Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female subjects must be of Non- child-bearing potential
Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria:

Presence of any clinically significant illness
Abnormal vital signs
History of any conditions that may put the subject at risk by participating in the study
Participation in another clinical study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771979

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: AZD0530 Clinical Trials		AZD0530ClinicalTrialsMailbox@astrazeneca.com

Locations

United Kingdom
Research Site	Recruiting
Alderley Park, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Raj Chetty, MD	AstraZeneca, Clinical Pharmacolgy Unit, Alderley Park
Study Director:	Mary Stuart, MD	AstraZeneca,Parklands, Alderley Park

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology )
Study ID Numbers:	D8180C00033
Study First Received:	October 14, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00771979
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Healthy Volunteers
Relative Bioavailability

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009