Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects

Study Overview
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Brief Summary
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Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in healthy adult male subjects to assess the absorption, metabolism, and excretion of [14C]-Ecopipam in Healthy Male Subjects.

Detailed Description
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This study will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 29 days prior to dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until at least Day 8 (Discharge). On Day 1, subjects will receive a single oral dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of [14C]-ecopipam HCl. Subjects will be discharged when the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections; ≥ 90% mass balance recovery; and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which collections occur. If discharge criteria are not met on Day 8, subjects will remain in the CRU and additional 24-hour collections (blood, urine, and feces) for total radioactivity will continue until these criteria are met, up to a maximum of Day 15.

Official Title
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A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam Following a Single Oral Capsule Dose in Healthy Male Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: [14C]-Ecopipam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males of any race between 35 and 55 years of age Body mass index between 18.0 and 30.0 kg/m2 In good health Males will agree to use contraception Able to comprehend and sign an informed consent form History of a minimum of 1 bowel movement per day Exclusion Criteria: History of significant medical illness History of clinically significant drug allergy History of a seizure disorder, not including infantile seizures History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs Clinically significant medical treatment within 8 weeks or infection treatment within 4 weeks of dosing Clinically significant ECG abnormality History of alcoholism or drug/chemical abuse within the previous 2 years or positive screening test Significant alcohol consumption Positive hepatitis panel and/or positive human immunodeficiency virus test Use of prohibited prescription, over-the-counter medications or natural health products Use of tobacco or nicotine-containing products within 3 months prior to Check-in or positive screening test Receipt of blood products within 2 months prior to Check in Recent donation of blood, plasma, or platelets prior to Screening Exposure to significant diagnostic, therapeutic or employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in Evidence or history of active suicidal thoughts in the previous 5 years or have any lifetime history of a suicide attempt Not suitable for study in the opinion of the Principal Investigator

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 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: [14C]-Ecopipam<br>Single oral capsule dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of [14C]-ecopipam HCl | Drug: [14C]-Ecopipam<br>* [14C]-Ecopipam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of radioactivity excreted in urine (Aeu) | Up to 18 urine samples will be collected at the indicated time points | Up to Day 15 | 
| Cumulative radioactivity excreted in urine (Aeu) | Up to 18 urine samples will be collected at the indicated time points | Up to Day 15 | 
| Amount of radioactivity excreted in feces (Aef) | Up to 16 feces samples will be collected at the indicated time points | Up to Day 15 | 
| Cumulative radioactivity excreted in feces (Aef) | Up to 16 feces samples will be collected at the indicated time points | Up to Day 15 | 
| Percentage of dose excreted in urine (feu) | Up to 18 urine samples will be collected at the indicated time points | Up to Day 15 | 
| Percentage of dose excreted in feces (fef) | Up to 16 feces samples will be collected at the indicated time points | Up to Day 15 | 
| Cumulative dose excreted in urine (feu) | Up to 18 urine samples will be collected at the indicated time points | Up to Day 15 | 
| Cumulative dose excreted in feces (fef) | Up to 16 feces samples will be collected at the indicated time points | Up to Day 15 | 
| Percentage of total radioactivity in total excreta (feces + urine) | Up to 18 urine and feces samples will be collected at the indicated time points | Up to Day 15 | 
| Area under the plasma concentration versus time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| AUC from time zero to the last quantifiable concentration (AUC0 last) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Maximum observed concentration (Cmax) radioactivity feces + urine) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Time of Cmax (Tmax) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Apparent terminal elimination half-life (t1/2) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Apparent total clearance (CL/F; ecopipam only) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Apparent volume of distribution (Vz/F; ecopipam only) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| AUC0-inf of plasma ecopipam concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Plasma ecopipam/Total Radioactivity Ratio) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0 inf Blood/Plasma Ratio) | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ecopipam and metabolites to total radioactivity in plasma | Up to 28 blood samples will be collected at the indicated time points | Up to Day 15 | 
| Percentage of ecopipam and metabolites to total radioactivity in urine and faeces | Up to 18 urine and faeces samples will be collected at the indicated time points | Up to Day 15 |