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Completed

NCT Number: NCT02402595

Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts

The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

About this study

A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult males and females, 18 to 55 years of age
  • Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)

Exclusion criteria

  • History or presence of significant disease
  • History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
  • Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
  • Use of any prescription or the over-the-counter medications within 14 days

Treatment and study plan

AVP-923

Drug

AVP-786

Drug

Itraconazole

Drug

Other names: Sporanex

Primary outcomes

  1. Change in plasma concentration of AVP-923 after dosing in combination with itraconazole

    Time frame: 16 Days

  2. Change in plasma concentration of AVP-786 after dosing in combination with itraconazole

    Time frame: 16 Days

Secondary outcomes

  1. Incidence of adverse events (AEs) for AVP-923 and itraconazole

    Time frame: 16 Days

  2. Incidence of adverse events (AEs) for AVP-786 and itraconazole

    Time frame: 16 Days

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects

Acronym: DDI

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Apr 28, 2026

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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