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Completed

NCT Number: NCT02545439

A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

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Key information

Conditions

Healthy Volunteers

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 lifetime 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 or 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 given alone and in conjunction with Rifampin

Primary outcomes

  1. AUCinf

    Time frame: Up to 72 hours

    Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin

  2. AUClast

    Time frame: Up to 72 hours

    Area under the concentration time curve from time 0 to the last measurable timepoint in the presence and absence of rifampin

  3. Cmax

    Time frame: Up to 72 hours

    Maximum plasma concentration in the presence and absence of rifampin.

Secondary outcomes

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

    Time frame: UP to 27 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 10, 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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