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Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771979
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : June 18, 2009
Information provided by:

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 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : November 2008
Actual Study Completion Date : March 2009

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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771979

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United Kingdom
Research Site
Alderley Park, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Raj Chetty, MD AstraZeneca, Clinical Pharmacology Unit, Alderley Park
Study Director: Mary Stuart, MD AstraZeneca,Parklands, Alderley Park

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Responsible Party: Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals Identifier: NCT00771979    
Other Study ID Numbers: D8180C00033
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009
Keywords provided by AstraZeneca:
Healthy Volunteers
Relative Bioavailability
Additional relevant MeSH terms:
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Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action