Expired Study
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Austin, Texas 78744


Purpose:

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


Criteria:

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


NCT ID:

NCT02504463


Primary Contact:

Study Director
Arielle Stanford, MD
Alkermes Medical Director


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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