Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects
June 24, 2015 updated by: AstraZeneca
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Single Ascending Doses in Healthy Male and/or Female Subjects
The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females.
The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.
Study Overview
Study Type
Interventional
Enrollment (Actual)
203
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nottingham, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated, written informed consent
- Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture
- Body mass index of between 18 and 30 kg/m2 inclusive
Exclusion Criteria:
- Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate in the study
- Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
- Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo oral solution
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Single dose of oral solution.
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Experimental: Active
AZD5069 oral solution
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Single dose of oral solution.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.
Time Frame: Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3.
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Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Pharmacokinetic profile: concentration of AZD5069 in blood
Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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Measurement of the effect of AZD5069 on circulating neutrophils
Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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Pharmacodynamic profile: assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood
Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Sparrow, BSc, BMedSci, BM,BS, AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
August 5, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- D3550C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.