Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00771979
First received: October 14, 2008
Last updated: June 17, 2009
Last verified: June 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

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 ]

Enrollment: 18
Study Start Date: November 2008
Study Completion Date: March 2009
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00771979     History of Changes
Other Study ID Numbers: D8180C00033
Study First Received: October 14, 2008
Last Updated: June 17, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Healthy Volunteers
Relative Bioavailability

Additional relevant MeSH terms:
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014