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NCT04081363 · ClinicalTrials.gov registry record · Phase 2

Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)

A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT04081363: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT04081363 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04081363, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection in future trials.

Interventions

  • DRUG Centanafadine

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-10-07
Est. Completion 2019-12-21
Phase Phase 2

What the finished NCT04081363 record still lists

NCT04081363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Centanafadine is the first listed.

NCT04081363 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04081363 about?

NCT04081363 is a clinical study titled "Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)". With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection ...

What is the current status of trial NCT04081363?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-10-07. Estimated completion is 2019-12-21.

What interventions are being tested in trial NCT04081363?

The interventions under investigation include: Centanafadine (DRUG).

Who is sponsoring clinical trial NCT04081363?

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 NCT04081363's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04081363, the US trial registry maintained by the National Library of Medicine. NCT04081363 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.