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

Sponsor

Vallon Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04647903

Collaborator

(none)

Enrollment

Location

Arms

14.4

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD Narcolepsy	Drug: ADAIR 10 mg IR tablets Drug: d-amphetamine sulfate Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2020

Actual Primary Completion Date :

Dec 17, 2021

Actual Study Completion Date :

Dec 17, 2021

Arms and Interventions

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: d-amphetamine sulfate crushed d-amphetamine sulfate 3x10mg Other Names: dextroamphetamine sulfate Drug: Placebo placebo for oral and intranasal administration
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 Oral Placebo + Intranasal Placebo	Drug: Placebo placebo for oral and intranasal administration

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vallon Investigational Site	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Vallon Pharmaceuticals, Inc.

Investigators

Study Director: Timothy Whitaker, M, Vallon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vallon Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04647903

Other Study ID Numbers:

VAL-104

First Posted:

Dec 1, 2020

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Narcolepsy

Amphetamine

Dextroamphetamine

Study Results

No Results Posted as of Dec 29, 2021