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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02504463

Run by

Alkermes, Inc.

People needed

10

Starts

2015-06-01

Expected to finish

2015-09-01

Last updated by the study team

2015-09-18

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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