A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)

Phase 1

Completed

• Conditions: Attention-Deficit Hyperactivity Disorder
• Interventions: Drug: HLD100-B; Drug: HLD100-C; Drug: HLD100-E

• Registration Number: NCT01886469
• Lead Sponsor: Ironshore Pharmaceuticals and Development, Inc

Brief Summary

The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Study Start: 2013-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children (6-11 yrs)	HLD100-B	-
Children (6-11 yrs)	HLD100-C	-
Adolescents (12-17yrs)	HLD100-E	-
Adolescents (12-17yrs)	HLD100-B	-
Adolescents (12-17yrs)	HLD100-C	-
Children (6-11 yrs)	HLD100-E	-

Primary Outcome Measures

Name	Time	Method
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)	48hrs

Secondary Outcome Measures

Name	Time	Method
Safety (AEs, ECG, laboratory parameters, physical examinations)	48 hours

Trial Locations

Locations (1)

Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing; 🇨🇦 Saskatoon, Saskatchewan, Canada