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OpenTrials
Completed

NCT Number: NCT02068105

A Study of ALKS 5461 in Healthy Volunteers

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

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Key information

Conditions

Pharmacokinetics

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

  • 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

Treatment and study plan

ALKS 5461

Drug

Sublingual tablet

Placebo

Drug

Sublingual tablet

Primary outcomes

  1. Relative bioavailability of ALKS 5461 treatment groups

    Time frame: 21 days

    The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).

Secondary outcomes

  1. Safety and tolerability: Incidence of adverse events

    Time frame: 21 days

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2014
Registry last updated
Apr 21, 2014

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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