Healthy Volunteers
Conditions
Keywords
Alkermes, Samidorphan, ALKS 5461, Healthy Volunteer, Pharmacokinetics
Brief summary
This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.
Interventions
DRUGALKS 5461
Sublingual tablet given alone and in conjunction with Rifampin
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf | Up to 72 hours | Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin |
| AUClast | Up to 72 hours | Area under the concentration time curve from time 0 to the last measurable timepoint in the presence and absence of rifampin |
| Cmax | Up to 72 hours | Maximum plasma concentration in the presence and absence of rifampin. |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be measured by the incidence of Adverse Events | UP to 27 days |
Countries
United States
Outcome results
None listed