Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931

Study Overview
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Brief Summary
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Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration

Official Title
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[14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C] AZD8931


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) of ≥19 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-smokers or ex-smokers who have stopped smoking for >3 months before Visit 1 and have not used nicotine products for >3 months Healthy Male volunteers aged 50 to 65 years, inclusive 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 12 months of the screening visit (Visit 1). History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)

Ages Eligible for Study
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Minimum Age: 50 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD8931<br>[14C] AZD8931 | Drug: [14C] AZD8931<br>* Single 160 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 AZD931 in human subjects |  | Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose | 
| To investigate the pharmacokinetic variable of AZD8931 in plasma |  | Multiple PK blood samples from pre-dose until 240 hours post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of AZD8931 given orally |  | Frequent safety measurements during the study from screening period to follow-up | 
| To investigate the AZD8931 metabolites variables in plasma |  | Multiple PK blood samples from pre-dose until 240 hours post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers