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

NCT04232644 | Completed Phase 1 FDA Drug

• 1 other identifier: VAL-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD; Narcolepsy

Outcome Measures

Primary Outcomes (4)

• Treatment-emergent adverse event reporting

  Assess the safety and tolerability as measured by the incidence, frequency, and severity of treatment-emergent adverse events

  Day 1 to Day 9 (Treatment Phase)

• Abnormal Vital Signs

  Number and percent of subjects with abnormal vital sign values

  Day 1 to Day 9 (Treatment Phase)

• Abnormal ECG Values

  Number and percent of abnormal ECG values

  Day 1 to Day 9 (Treatment Phase)

• Abnormal clinical laboratory results

  Number and percent of abnormal clinical laboratory results

  Day 1 to Day 9 (Treatment Phase)

Secondary Outcomes (15)

• Maximum Plasma Concentration (Cmax)

  Up to 24 hours post dose

• Time to Maximum Plasma Concentration (tmax)

  Up to 24 hours post dose

• Area Under the Plasma Concentration AUC0-1h

  Up to 24 hours post dose

• Area Under the Plasma Concentration AUC0-2h

  Up to 24 hours post dose

• Area Under the Plasma Concentration AUC0-4h

  Up to 24 hours post dose

Other Outcomes (2)

• Abuse Liability

  Up to 24 hours post dose

• Subjective Drug Value Assessment

  Up to 24 hours post dose

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

crushed d-amphetamine IR tablets

Drug: ADAIR 10mg IR capsules; Drug: Crushed d-amphetamine sulfate IR tablets

Treatment B

EXPERIMENTAL

manipulated ADAIR IR capsules

Drug: ADAIR 10mg IR capsules; Drug: Crushed d-amphetamine sulfate IR tablets

Interventions

ADAIR 10mg IR capsules DRUG

manipulated ADAIR IR 3x10 mg capsules

Treatment A; Treatment B

Crushed d-amphetamine sulfate IR tablets DRUG

crushed d-amphetamine sulfate IR 6 x 5 mg tablets

Treatment A; Treatment B

Eligibility Criteria

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

You may qualify if:

• BMI within 18.5-32.0 kg/m2 and min weight of 50.0 kg
• healthy, according to med history, ECG, vital signs, lab results and physical exam
• clinical lab values within acceptable lab test range, unless otherwise deemed acceptable by PI
• SBP between 95-140 mmHg and DBP between 55-90 mmHg and HR between 50-100 bpm unless deemed not clinically significant by PI
• current or history of stimulant use for recreational purposes at least 10 times in lifetime and used stimulants at least once in the 12 weeks before screening
• experience with intranasal drug use for the purpose of recreational use on at least 3 occasions in the year prior to Screening
• ability to fast for at least 12 hours and consume standard meals
• agree not to have tattoo or body piercing until end of study
• female subject must be non-pregnant and non-lactating and fulfill at least one of following: participant is of childbearing potential and had used one of accepted contraception regimens from at least 30 days prior to first study drug and agrees to use two acceptable contraceptive regiment through at least 30 days after last dose of study drug or participant is of non-childbearing potential, defined as surgically sterile or is in a postmenopausal state
• a male subject must have met one of the following: participant is able to procreate and agreed to use one of accepted contraceptive regimens and not donate sperm from first study drug administration to at least 90 days after last drug administration or participant is unable to procreate, defined as surgically sterile and agreed to use a male condom from first study drug administration to at least 90 days after last drug administration

You may not qualify if:

• substance or alcohol dependence within the past 2 years
• history or presence of clinically significant abnormality as assessed by physical exam, med history, ECGs, vital signs, or lab results which in the opinion of the investigator would jeopardize the safety or the subject or validity of the study results
• history or presence of cardiovascular disorder, pre-existing structural cardiac abnormalities or other serious cardiac problems, prolonged QT syndrome, and associated risk factors
• abnormalities in the intranasal cavity or any condition that in the opinion of the PI would interfere with study procedures, data integrity, or compromise the safety of the subjects
• history or presence of mechanical gastrointestinal obstruction or any disease/conditions that affect bowel transit
• documented history of, or currently active, seizure disorder or history of clinically significant head injury or syncope of unknown origin
• history or presence of any psychiatric or neurological condition that, in the opinion of the PI, could get exacerbated by study drug exposure or interfere with study procedures
• subject with history of suicidal ideation or suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale
• heavy smoker (\>20 cigarettes per day) and/or is unable to abstain from smoking for a least 6 hours during the in-clinic periods
• history of severe allergic reaction to any substance, severe bronchial asthma, chronic obstructive airway, or previous status asthmaticus
• history of allergy or hypersensitivity to amphetamine salts, its excipients, or related substances
• history of food allergies, including lactose, and/or presence of any dietary restrictions
• positive test results for any of the following: HIV, Hep B, Hep C, positive drug screen at admission to the Qualification Phase or Treatment Phase, breath alcohol test and positive pregnancy test for females
• evidence of clinically significant hepatic or renal impairment including ALT or AST\>1.5x the upper limit of normal (ULN) or bilirubin \>1xULN
• known history or presence of: seizures or risk of seizure; tics or Tourette's Syndrome; psychosis, mania, bipolar disorder, suicidality or violent behavior; hyperthyroidism; Raynaud's Phenomenon; eye disorders

Sponsors & Collaborators

• Vallon Pharmaceuticals, Inc.: lead

Study Sites (1)

BioPharma Services Inc.

Toronto, Ontario, M9L 3A2, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Narcolepsy

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

Study Officials

• Timothy Whitaker, MD

  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: January 10, 2020
• First Posted: January 18, 2020
• Study Start: May 27, 2019
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

CA (1)