A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

Study Overview
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Brief Summary
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This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.

Official Title
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A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Samidorphan IV
* Drug: [14c]-Samidorphan sublingual
* Drug: [14c]-Samidorphan oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m^2 at screening (minimum weight of 50.0 kg) Generally good health Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method Additional criteria may apply Exclusion Criteria: Clinically significant illness within 30 days History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines History of oral or gastrointestinal disease Irregular bowel or bladder function History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone) Current or pending legal charges or probation that would interfere with study conduct Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission Tobacco or nicotine use within 90 days Anticipated need for prescription medicines during the study period Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Samidorphan IV<br>Samidorphan solution for IV administration | Drug: Samidorphan IV<br>* Single IV administration<br>|
| Experimental: Samidorphan sublingual<br>[14c]-Samidorphan for sublingual administration | Drug: [14c]-Samidorphan sublingual<br>* Single sublingual administration containing radiolabel<br>|
| Experimental: Samidorphan oral<br>[14c]-Samidorphan for oral administration | Drug: [14c]-Samidorphan oral<br>* Single oral administration containing radiolabel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-t | Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma | Up to 120 hours after each dose | 
| Cmax | Maximum concentration of total radioactivity in blood and plasma | Up to 120 hours after each dose | 
| Tmax | Time to maximum concentration of total radioactivity in blood and plasma | Up to 120 hours after each dose | 
| Fe%0-t | Fraction of dose excreted in urine and feces | Up to 120 hours after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be measured by the incidence of Adverse Events |  | Up to 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, Samidorphan, ALKS 33, Healthy Volunteer, Pharmacokinetics