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NCT02402595 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT02402595: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT02402595 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02402595, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Itraconazole
  • DRUG AVP-923
  • DRUG AVP-786

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2015-03-01
Est. Completion 2015-07-01
Phase Phase 1

What the finished NCT02402595 record still lists

NCT02402595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.

NCT02402595 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02402595 about?

NCT02402595 is a clinical study titled "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.

What is the current status of trial NCT02402595?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-03-01. Estimated completion is 2015-07-01.

What interventions are being tested in trial NCT02402595?

The interventions under investigation include: Itraconazole (DRUG), AVP-923 (DRUG), AVP-786 (DRUG).

Who is sponsoring clinical trial NCT02402595?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02402595's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02402595, the US trial registry maintained by the National Library of Medicine. NCT02402595 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.