A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02504463
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Samidorphan IV Samidorphan IV Samidorphan solution for IV administration Samidorphan sublingual [14c]-Samidorphan sublingual \[14c\]-Samidorphan for sublingual administration Samidorphan oral [14c]-Samidorphan oral \[14c\]-Samidorphan for oral administration
- Primary Outcome Measures
Name Time Method AUC 0-t Up to 120 hours after each dose Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Cmax Up to 120 hours after each dose Maximum concentration of total radioactivity in blood and plasma
Fe%0-t Up to 120 hours after each dose Fraction of dose excreted in urine and feces
Tmax Up to 120 hours after each dose Time to maximum concentration of total radioactivity in blood and plasma
- Secondary Outcome Measures
Name Time Method Safety and tolerability will be measured by the incidence of Adverse Events Up to 35 days
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇺🇸Austin, Texas, United States