Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00771979

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD0530 Drug: AZD0530	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Nov 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.

Arm

Intervention/Treatment

Experimental: 1

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.

Outcome Measures

Primary Outcome Measures

To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. [Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.]

Secondary Outcome Measures

To monitor 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.]
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 [Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Alderley Park		United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00771979

Other Study ID Numbers:

D8180C00033

First Posted:

Oct 15, 2008

Last Update Posted:

Jun 18, 2009

Last Verified:

Jun 1, 2009

Keywords provided by , ,

Healthy Volunteers

Relative Bioavailability

Additional relevant MeSH terms:

Saracatinib

Study Results

No Results Posted as of Jun 18, 2009