A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | October 2015 |
A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461
This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics
of ALKS 5461.
of ALKS 5461.
Inclusion Criteria:
- Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
- Is in good physical health
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
Exclusion Criteria:
- Is currently pregnant or breastfeeding
- Has a lifetime history of substance abuse disorder
- Has used nicotine within 90 days prior to the study or anticipates a need to use
nicotine during the study period
- Has used any prescription or over-the-counter medication, including natural health
products or dietary supplements (with the exception or prescription contraceptives or
hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
prior to study start
- Has used opioids within 30 days prior to screening, or has an anticipated need for
opioid medication at any point during the study
- Has used alcohol within 72 hours prior to any inpatient period
- Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per
day)
- Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid
antagonists (naltrexone, naloxone)
- Additional criteria may apply
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