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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJune 18, 2009
June 1, 2009
October 14, 2008
June 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Study Arms (1)
1
EXPERIMENTALInterventions
of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.
Eligibility Criteria
You may qualify if:
- Female subjects must be of Non- child-bearing potential
- Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Alderley Park, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Raj Chetty, MD
AstraZeneca, Clinical Pharmacology Unit, Alderley Park
- STUDY DIRECTOR
Mary Stuart, MD
AstraZeneca,Parklands, Alderley Park
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
November 1, 2008
Study Completion
March 1, 2009
Last Updated
June 18, 2009
Record last verified: 2009-06