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

April 23, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Vince and Associates Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: Itraconazole
Other Names:
  • Sporanex
Drug: AVP-923
Experimental: Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: Itraconazole
Other Names:
  • Sporanex
Drug: AVP-786
Experimental: Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: Itraconazole
Other Names:
  • Sporanex
Drug: AVP-786
Experimental: Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: Itraconazole
Other Names:
  • Sporanex
Drug: AVP-923

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
Time Frame: 16 Days
16 Days
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
Time Frame: 16 Days
16 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs) for AVP-923 and itraconazole
Time Frame: 16 Days
16 Days
Incidence of adverse events (AEs) for AVP-786 and itraconazole
Time Frame: 16 Days
16 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Principal Investigator: Martin Kankam, MD, PhD, MPH, Vince and Associates Clinical Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimated)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-AVP-786-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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