CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
SHP465drug
Likely dose
SHP465 6.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03327402
NCT03327402Phase 1Completed
CompareCT.gov

A Phase 1 Open-label Study of the Safety, Tolerability, and Pharmacokinetics of d- and l-Amphetamine After Multiple Daily Doses of SHP465 6.25 mg Administered in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder

Shire·interventional·Posted Oct 31, 2017·Updated Jun 8, 2021

In Brief

A Phase 1 clinical trial evaluating SHP465 for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 24 participants across 8 sites.

Detailed Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of SHP465 in children aged 4 to 5 years with ADHD after multiple daily doses of 6.25 milligram (mg) SHP465

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 31, 2017
Enrollment StartMar 13, 2018
Primary CompletionOct 5, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.7 years ago

Interventions

SHP465drug

SHP465 capsule will be administered at a dose of 6.25 mg, orally once daily for 4 weeks. SHP465 is comprised of sulfate salts of dextroamphetamine and amphetamine, with dextroamphetamine saccharate and amphetamine aspartate monohydrate, which provide a composite enantiomer ratio of 3:1 d-amphetamine to l-amphetamine.