Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD0530; Drug: AZD0530

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Alderley Park, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion: December 7, 2022
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 14, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): June 18, 2009
• Last Update Submitted That Met QC Criteria: June 17, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Relative Bioavailability
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Saracatinib
• Other Study ID Numbers: D8180C00033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No