NCT04232644

Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)

A Pilot, Randomized, Double-Blind, Active-Controlled, 2-Treatment, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Abuse Liability of Dextroamphetamine Sulfate From an Abuse-Deterrent Immediate-Release Formulation (ADAIR)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vallon Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine sulfate IR formulation administered intranasally in non-dependent recreational stimulant users. The study is comprised of 4 phases: Screening, Qualification, Treatment, and Follow-up/Early Termination.

Detailed description

VAL-103 is a phase 1, pilot, randomized, double-blind, active-controlled, 2-treatment crossover study. The study objectives include assessing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of manipulated ADAIR 30 mg compared to crushed d-amphetamine sulfate IR 30 mg (DEX) administered IN in non-dependent recreational stimulant users. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale. A total of 16 qualified subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests, and Columbia Suicide Severity Rating Scale (C-SSRS).

Conditions

• ADHD
• Narcolepsy

Interventions

Type	Name	Description
DRUG	ADAIR 10mg IR capsules	manipulated ADAIR IR 3x10 mg capsules
DRUG	Crushed d-amphetamine sulfate IR tablets	crushed d-amphetamine sulfate IR 6 x 5 mg tablets

Timeline

• Start date: 2019-05-27
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2020-01-18
• Last updated: 2020-01-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study