Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (SEAL)

A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users

This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.

Study Overview

• Status: Completed
• Conditions: ADHD; Narcolepsy
• Intervention / Treatment: Drug: ADAIR 10 mg IR tablets; Drug: Placebo; Drug: d-amphetamine sulfate

Detailed Description

VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study objectives include assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.

A total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Vallon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female volunteers, 18 to 55 years of age inclusive
• Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS stimulant, >/= 1 abuse of CNS stimulant in the previous 3 months)
• Prior intranasal recreational drug abuse experience
• Body mass index (BMI) 18 to 33 kg/m2 inclusive

Exclusion Criteria:

• History of any significant disease or disorder
• History or current diagnosis of substance dependence (excluding caffeine and nicotine)
• Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
• Positive for hepatitis B, hepatitis C or HIV infection
• Pregnant or lactating women
• Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
• Confirmed positive drug screening
• Positive alcohol breath test at screening / any Day -1
• Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Placebo + Intranasal manipulated ADAIR; Oral Placebo + Intranasal manipulated ADAIR 30 mg	Drug: ADAIR 10 mg IR tablets; manipulated ADAIR 3x10mg; Other Names: ADAIR; Drug: Placebo; placebo for oral and intranasal administration
Active Comparator: Oral Placebo + Intranasal crushed dextroamphetamine sulfate; Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg	Drug: Placebo; placebo for oral and intranasal administration; Drug: d-amphetamine sulfate; crushed d-amphetamine sulfate 3x10mg; Other Names: dextroamphetamine sulfate
Experimental: Oral ADAIR + Intranasal Placebo; Oral ADAIR 30 mg + Intranasal Placebo	Drug: Placebo; placebo for oral and intranasal administration
Placebo Comparator: Oral Placebo + Intranasal Placebo	Drug: Placebo; placebo for oral and intranasal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Liking Emax Visual Analog Scale (VAS)	Peak effect for drug liking based on bipolar VAS from 0-100 scale	Up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Take Drug Again Emax VAS	Peak effect for take drug again based on bipolar VAS from 0-100 scale	Up to 24 hours post dose
Overall Drug Liking Emax VAS	Peak effect for overall drug liking based on bipolar VAS from 0-100 scale	Up to 24 hours post dose
Plasma concentrations (PK parameters)	plasma concentrations of ADAIR and dextroamphetamine sulfate	Up to 36 hours post dose
Safety (adverse events)	Incidence of adverse events	Day 1 to Day 18

Collaborators and Investigators

• Sponsor: Vallon Pharmaceuticals, Inc.
• Investigators: Study Director: Timothy Whitaker, M, Vallon Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Amphetamine; Dextroamphetamine
• Other Study ID Numbers: VAL-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently there is no IPD plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No