A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | September 2015 |
A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects
This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male
volunteers.
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
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