Healthy
Conditions
Keywords
Alkermes, Samidorphan, ALKS 5461, QT/QTc, Buprenorphine, Pharmacodynamics
Brief summary
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
Interventions
DRUGMoxifloxacin
Single administration
DRUGALKS 5461
Daily administration for a total of 12 dosing days
DRUGPlacebo
Placebo will be matched to Moxifloxacin or ALKS 5461
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening * Is physically healthy * Agree to abide by the contraception requirements for the duration of the study * Additional criteria may apply
Exclusion criteria
* Have a positive pregnancy test and/or be currently breastfeeding * Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV) * Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality * Have any skin condition likely to interfere with ECG electrode placement or adhesion * Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine) * Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose * Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose * Have used nicotine within 90 days prior to the first study drug dose * Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in QT interval corrected for heart rate using the Fridericia formula (QTcF) | Up to 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal ECG | Up to 13 days | — |
| Tabulation of ECG morphology | Up to 14 days | Findings not present at baseline |
| Correlation of plasma drug levels with QT interval | Up to 14 days | — |
| Maximum observed plasma concentration (Cmax) for ALKS 5461 | Up to 14 days | — |
| Incidence of adverse events (AEs) | Up to 14 weeks | — |
| Change in heart rate | Up to 14 days | — |
| Change in QRS interval | Up to 14 days | — |
| Time to reach the maximum plasma concentration (Tmax) for ALKS 5461 | Up to 14 days | — |
| AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461 | Up to 14 days | — |
| AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461 | Up to 14 days | — |
| Terminal elimination half-life (T1/2) for ALKS 5461 | Up to 14 days | — |
| Change in PR interval | Up to 14 days | — |
Countries
United States
Outcome results
None listed