Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

Study Overview
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Brief Summary
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This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C] AZD5069.

Official Title
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A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C] AZD5069


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg. Regular daily bowel movements (ie, production of at least 1 stool per day). Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1 Healthy Male volunteers aged 50 and over Exclusion Criteria: Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life Participation in any prior radiolabelled study within last 5 years History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>[14C] AZD5069 | Drug: [14C] AZD5069<br>* Single 120 mg oral dose administered on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood | To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)). | From pre-dose until 168 hours post last dose | 
| To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax). |  | From pre-dose until 168hours post last dose | 
| To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance. |  | From pre-dose until 168hours post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of AZD5069 given orally | Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported. | From screening visit, Day 12, up to follow up visit |