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

NCT04647903 | Completed Phase 1 FDA Drug

• 1 other identifier: VAL-104
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Narcolepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Take Drug Again Emax VAS

  Up to 24 hours post dose

• Overall Drug Liking Emax VAS

  Up to 24 hours post dose

• Plasma concentrations (PK parameters)

  Up to 36 hours post dose

• Safety (adverse events)

  Day 1 to Day 18

Study Arms (4)

Oral Placebo + Intranasal manipulated ADAIR

EXPERIMENTAL

Oral Placebo + Intranasal manipulated ADAIR 30 mg

Drug: ADAIR 10 mg IR tablets; Drug: Placebo

Oral Placebo + Intranasal crushed dextroamphetamine sulfate

ACTIVE COMPARATOR

Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg

Drug: d-amphetamine sulfate; Drug: Placebo

Oral ADAIR + Intranasal Placebo

EXPERIMENTAL

Oral ADAIR 30 mg + Intranasal Placebo

Drug: Placebo

Oral Placebo + Intranasal Placebo

PLACEBO COMPARATOR

Oral Placebo + Intranasal Placebo

Drug: Placebo

Interventions

ADAIR 10 mg IR tablets DRUG

manipulated ADAIR 3x10mg

Also known as: ADAIR

Oral Placebo + Intranasal manipulated ADAIR

d-amphetamine sulfate DRUG

crushed d-amphetamine sulfate 3x10mg

Also known as: dextroamphetamine sulfate

Oral Placebo + Intranasal crushed dextroamphetamine sulfate

Placebo DRUG

placebo for oral and intranasal administration

Oral ADAIR + Intranasal Placebo; Oral Placebo + Intranasal Placebo; Oral Placebo + Intranasal crushed dextroamphetamine sulfate; Oral Placebo + Intranasal manipulated ADAIR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vallon Pharmaceuticals, Inc.: lead

Study Sites (1)

Vallon Investigational Site

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Narcolepsy

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Timothy Whitaker, M

  Vallon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 1, 2020
• Study Start: October 5, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)