A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.

Official Title
-----------------
A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD2927
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP) Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg 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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Abnormal vital signs, after 10 minutes supine rest Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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: AZD2927<br>* Single dose of AZD2927<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Single dose of placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2927, at screening |  | Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening | 
| Safety and tolerability of AZD2927, day 1 |  | Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1. | 
| Safety and tolerability of AZD2927, day 2 |  | Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2. | 
| Safety and tolerability of AZD2927, day 3 |  | Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3. | 
| Safety and tolerability of AZD2927, at follow up |  | Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1 |  | Pharmacokinetic sampling will be performed day 1 | 
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2 |  | Pharmacokinetic sampling will be performed day 2 | 
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3 |  | Pharmacokinetic sampling will be performed day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, pharmacokinetics, drug metabolism