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NCT02578030 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD

A Phase 1 study, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT02578030: Completed Phase 1 study, sponsored by Shire.

NCT02578030 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02578030, a Phase 1 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).

Primary Outcome

Maximum concentration occurring at time of maximum observed concentration of d-amphetamine during a dosing interval.

Interventions

  • DRUG SHP465 12.5mg
  • DRUG SHP465 25mg

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2015-10-24
Est. Completion 2015-11-10
Phase Phase 1
Shire

245 total trials

What the finished NCT02578030 record still lists

NCT02578030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which SHP465 12.5mg is the first listed.

NCT02578030 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02578030 about?

NCT02578030 is a clinical study titled "Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD". To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).

What is the current status of trial NCT02578030?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-10-24. Estimated completion is 2015-11-10.

What interventions are being tested in trial NCT02578030?

The interventions under investigation include: SHP465 12.5mg (DRUG), SHP465 25mg (DRUG).

Who is sponsoring clinical trial NCT02578030?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02578030's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 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 NCT02578030, the US trial registry maintained by the National Library of Medicine. NCT02578030 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.