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Completed

NCT Number: NCT02521857

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ALKS 5461

Drug

Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints

Primary outcomes

  1. AUCinf

    Time frame: Up to 72 hours

    Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461

  2. AUClast

    Time frame: Up to 72 hours

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461

  3. Cmax

    Time frame: Up to 72 hours

    Maximum observed plasma concentration for ALKS 5461

Secondary outcomes

  1. Safety and tolerability will be measured by the incidence of Adverse Effects

    Time frame: Up to 46 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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