A Water Consumption Study of ALKS 5461 in Healthy Volunteers

A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02521857

Enrollment

Registered

2015-08-13

Start date

2015-07-31

Completion date

2015-09-30

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Alkermes, Samidorphan, ALKS 5461, Healthy Volunteer, Pharmacokinetics

Brief summary

This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.

Interventions

DRUGALKS 5461

Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints

Study design

Allocation

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 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 of 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 plasma concentration-time curve from time 0 to infinity for ALKS 5461
AUClast	Up to 72 hours	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Cmax	Up to 72 hours	Maximum observed plasma concentration for ALKS 5461

Secondary

Measure	Time frame
Safety and tolerability will be measured by the incidence of Adverse Effects	Up to 46 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026