A Study of ALKS 5461 in Healthy Volunteers

A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02068105

Enrollment

104

Registered

2014-02-21

Start date

2014-01-31

Completion date

2014-03-31

Last updated

2014-04-21

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

Conditions

Pharmacokinetics

Keywords

ALKS 5461, samidorphan

Brief summary

This is a study to test the safety of ALKS 5461 in healthy adults.

Interventions

DRUGALKS 5461

Sublingual tablet

DRUGPlacebo

Sublingual tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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

* Be in good physical health * Body mass index of 18-30 kg/m2 * Agree to use an approved method of birth control for the duration of the study * Additional criteria may apply

Exclusion criteria

* Currently pregnant or breastfeeding * History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV) * Current or history of any clinically significant medical or psychiatric condition * Current abuse or dependence on alcohol or any illicit drugs * Have used nicotine within 90 days * Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days * Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days * Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study * Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * Additional criteria may apply

Design outcomes

Primary

Measure	Time frame	Description
Relative bioavailability of ALKS 5461 treatment groups	21 days	The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).

Secondary

Measure	Time frame
Safety and tolerability: Incidence of adverse events	21 days

Countries

United States

Outcome results

None listed

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