A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02521857

Run by

Alkermes, Inc.

People needed

30

Starts

2015-07-01

Expected to finish

2015-09-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Alkermes Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.