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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14c]-Samidorphan oral; Drug: [14c]-Samidorphan sublingual; Drug: Samidorphan IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504463

ALK33-B107

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Samidorphan IV

Experimental group

Description:

Samidorphan solution for IV administration

Treatment:

Drug: Samidorphan IV

Samidorphan sublingual

Experimental group

Description:

\[14c\]-Samidorphan for sublingual administration

Treatment:

Drug: [14c]-Samidorphan sublingual

Samidorphan oral

Experimental group

Description:

\[14c\]-Samidorphan for oral administration

Treatment:

Drug: [14c]-Samidorphan oral