A Study of ALKS 5461 in Healthy Volunteers

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: ALKS 5461; Drug: Placebo

• Registration Number: NCT02068105
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-18
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ALKS 5461-A	ALKS 5461	-
ALKS 5461-B	ALKS 5461	-
ALKS 5461 Dose 1	ALKS 5461	-
ALKS 5461 Dose 2	ALKS 5461	-
Placebo	Placebo	-
ALKS 5461 Dose 3	ALKS 5461	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability: Incidence of adverse events	21 days

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States