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
1 other identifier
interventional
30
1 country
1
Brief Summary
This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2015
Shorter than P25 for phase_1 healthy
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
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 10, 2015
November 1, 2015
2 months
August 11, 2015
November 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
AUCinf
Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Up to 72 hours
AUClast
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Up to 72 hours
Cmax
Maximum observed plasma concentration for ALKS 5461
Up to 72 hours
Secondary Outcomes (1)
Safety and tolerability will be measured by the incidence of Adverse Effects
Up to 46 days
Study Arms (1)
ALKS 5461
EXPERIMENTALSublingual tablet
Interventions
Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
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
Arielle Stanford, MD
Alkermes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 13, 2015
Study Start
July 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 10, 2015
Record last verified: 2015-11