Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.

Study Overview
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Brief Summary
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The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Official Title
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A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AZD8566 in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: AZD8566
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent. Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG Females who are permanently or surgically sterile or postmenopausal. Exclusion Criteria: Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug History of any convulsions or seizures History of infection or at risk of infection due to recent surgery or trauma History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8566<br>* solution. Specific dose will be selected by the safety review committee<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Single 10ml oral solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD8566 in blood |  | Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose | 
| Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events |  | Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD8566 in urine |  | Samples collected over 48 hours from pre-dose to 48 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, Safety, Tolerability, AZD8566, study