Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Official Title
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A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD2423
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture 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 3 months of the first administration of investigational product

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD2423 | Drug: AZD2423<br>* oral, single administration<br>|
| Experimental: B<br>Placebo | Drug: Placebo<br>* oral administration and single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits. |  | 3 day residential period plus 7-10 days follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423. |  | 3 day residential period plus 7-10 days follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, healthy, pharmacokinetics