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HLD100-B

Phase 1

Attention-Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Collegium Pharmaceutical, Inc.|Last Updated: Oct 3, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

HLD100-B · 1 trial · 1 indication

Phase 1 1
NCT01886469A 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)Attention-Deficit Hyperactivity Disorder
COMPLETED22 Analytics
PHASE1COMPLETED
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)
Attention-Deficit Hyperactivity Disorder
NCT0188646922
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Safety (AEs, ECG, laboratory parameters, physical examinations)
48 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Adolescents (12-17yrs)EXPERIMENTAL -
Children (6-11 yrs)EXPERIMENTAL -

Interventions

NameTypeDescription
HLD100-BDRUGd-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)
HLD100-CDRUGd-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.
HLD100-EDRUGd-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Main Inclusion Criteria * Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2). * Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS). * ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedr...

Countries:Canada
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Frequently asked questions about HLD100-B

What is HLD100-B used for?

HLD100-B is an investigational small molecule being studied for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). It is a modified release amphetamine formulation under development by Collegium Pharmaceutical, Inc. The drug is currently in Phase 1 clinical development.

Who makes HLD100-B?

HLD100-B is being developed by Collegium Pharmaceutical, Inc., a company traded on the NASDAQ under the ticker symbol COLL. The drug is an investigational modified release amphetamine formulation intended for the treatment of Attention-Deficit Hyperactivity Disorder.

What phase is HLD100-B in?

HLD100-B is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) as a modified release amphetamine formulation.

What clinical trials is HLD100-B in?

HLD100-B has been studied in one completed clinical trial, NCT01886469, which examined the pharmacokinetic and pharmacodynamic effects of modified release amphetamine formulations in adolescents and children with Attention-Deficit Hyperactivity Disorder. The trial enrolled 22 participants in Canada and included patients as young as 6 years old.

Is HLD100-B the same as HLD100?

HLD100-B is one of several modified release amphetamine formulations, including HLD100 formulations B, C, and E, that were evaluated in a clinical trial for Attention-Deficit Hyperactivity Disorder. The trial was designed to compare the pharmacokinetic and pharmacodynamic effects of these different formulations.