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
1 other identifier
interventional
104
1 country
1
Brief Summary
This is a study to test the safety of ALKS 5461 in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 21, 2014
April 1, 2014
2 months
February 12, 2014
April 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative bioavailability of ALKS 5461 treatment groups
The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).
21 days
Secondary Outcomes (1)
Safety and tolerability: Incidence of adverse events
21 days
Study Arms (6)
ALKS 5461-A
EXPERIMENTALALKS 5461-B
EXPERIMENTALALKS 5461 Dose 1
EXPERIMENTALALKS 5461 Dose 2
EXPERIMENTALALKS 5461 Dose 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
Alkermes Investigational Site
Overland Park, Kansas, 66212, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Randall Marshall, MD
Alkermes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 21, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 21, 2014
Record last verified: 2014-04