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OpenTrials
Completed

NCT Number: NCT02272764

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

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

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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

  • Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
  • 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

  • Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
  • Is currently pregnant or breastfeeding
  • Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
  • Has a lifetime history of opioid abuse or dependence
  • Has current abuse or dependence on alcohol or any drugs
  • Has used nicotine within 90 days prior to randomization
  • Additional criteria may apply

Treatment and study plan

Itraconazole

Drug

Administered orally in a crossover design

Other names: Itraconazole or placebo

ALKS 5461

Drug

Administered sublingually in a crossover design

Other names: ALKS 5461 or placebo

Primary outcomes

  1. Drug-Drug Interaction - AUC0-t

    Time frame: Up to 48 hours

    Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole

  2. Drug-Drug Interaction - AUC0-inf

    Time frame: Up to 48 hours

    Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole

  3. Drug-Drug Interaction - Cmax

    Time frame: Up to 48 hours

    Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole

Secondary outcomes

  1. Safety and tolerability will be measured by incidence of adverse events

    Time frame: Up to 32 Days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 23, 2014
Registry last updated
Dec 12, 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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