Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551

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 AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body

Official Title
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A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD2551
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg Exclusion Criteria: Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome

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

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD2551<br>* Single dose of oral solution.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Single dose of oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events |  | Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3 | 
| Pharmacokinetic profile: concentration of AZD2551 in blood |  | Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD2551 in urine |  | Samples collected at Visit 2 from pre-dose up 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, Single Ascending Dose, Safety, Tolerability, AZD2551, Healthy Volunteer Study