Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.

Official Title
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A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD5122
* Drug: Placebo
* Drug: AZD5122


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated, written informed consent. Normal physical examination, laboratory values, blood pressure and pulse Healthy male caucasian subjects Exclusion Criteria: Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body. Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function Subjects must not have crystals or more than a trace of blood in their urine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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>AZD5122 oral suspension (part A and B) | Drug: AZD5122<br>* A single dose of oral suspension<br>|
| Placebo Comparator: 2<br>Placebo oral suspension (part A) | Drug: Placebo<br>* A single dose of oral suspension<br>|
| Experimental: 3<br>AZD5122 oral and IV infusion (part B) | Drug: AZD5122<br>* A single dose of oral suspension<br>Drug: AZD5122<br>* A single intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD5122 in blood |  | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD5122 in urine |  | 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 AZD5122 on circulating neutrophils |  | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. | 
| Pharmacodynamic profile: assessment of various pharmacodynamic measures |  | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals 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, healthy subjects, AZD5122, single oral dose, phase 1, Healthy volunteer phase 1 study