Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers

Study Overview
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Brief Summary
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Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Official Title
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An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers

Conditions
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Neuroscience

Intervention / Treatment
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* Drug: AZD2423


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) Provision of signed and dated, written informed consent prior to any study specific procedures Exclusion Criteria: Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) of >5 mSv in the last year, >10 mSv over 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 intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Single cohort of 6 subjects | Drug: AZD2423<br>* AZD2423<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 1 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 2 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 3 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 4 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 5 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 6 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 7 | 
| Percentage of radioactive dose recovered in urine and faeces and total percentage |  | During residential period on Day 8 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 1 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 2 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 3 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 4 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 5 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 6 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 7 | 
| Concentration of total radioactivity in blood and plasma |  | During residential period on Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination |  | Range of Day -1 until follow up visit (Visit 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioactive, ADME, Neuropathic pain