Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069

Study Overview
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Brief Summary
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This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.

Official Title
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A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD5069
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese subjects with suitable veins for cannulation or repeated venepuncture. Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product Exclusion Criteria: History of 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 subject's ability to participate in the study. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product. Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD5069<br>* Oral suspension<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry |  | From screening period to follow-up visit 42 days (Maximum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood |  | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose | 
| Measurement of the effect of AZD5069 on blood cells |  | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose | 
| Pharmacokinetic profile: concentration of AZD5069 in blood |  | Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Japanese healthy volunteer, AZD5069