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

Vallon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: ADHD; Narcolepsy

Treatments: Drug: ADAIR 10 mg IR tablets; Drug: Placebo; Drug: d-amphetamine sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04647903

VAL-104

Details and patient eligibility

About

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.

Full 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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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55 participants in 4 patient groups, including a placebo group

Oral Placebo + Intranasal manipulated ADAIR

Experimental group

Description:

Oral Placebo + Intranasal manipulated ADAIR 30 mg

Treatment:

Drug: Placebo

Drug: ADAIR 10 mg IR tablets

Oral Placebo + Intranasal crushed dextroamphetamine sulfate

Active Comparator group

Description:

Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg

Treatment:

Drug: Placebo

Drug: d-amphetamine sulfate

Oral ADAIR + Intranasal Placebo

Experimental group

Description:

Oral ADAIR 30 mg + Intranasal Placebo

Treatment:

Drug: Placebo

Oral Placebo + Intranasal Placebo

Placebo Comparator group

Description:

Oral Placebo + Intranasal Placebo

Treatment:

Drug: Placebo