ADHDPhase 1NCT04232644
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
A Phase 1 study testing ADAIR 10mg IR capsules and Crushed d-amphetamine sulfate IR tablets in people with ADHD and Narcolepsy, run by Vallon Pharmaceuticals, Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Narcolepsy
- What is being tested?
- ADAIR 10mg IR capsules and Crushed d-amphetamine sulfate IR tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2019to 17 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- individuals who have donated 50-499 mL of blood in the previous 30 days; or 500 mL or more in the previous 56 days
- donation of plasma by plasmapheresis within 7 days prior to first study drug administration
- difficulty with venous access or unsuitable or unwilling to undergo catheter insertion
- treatment with investigational drug within 5 times the elimination half-life, if known, or within 30 days prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with the study
- use of any prescription medication within 14 days prior to first study drug administration
- use of any OTC medications within 14 days prior to first study drug administration
- use of any prescription drugs, including MAO inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, buspirone, St. Johns Wort and all medications which are cytochrome P450 (CYP450) 2D6 inhibitors in the 30 days or 5 half-lives (whichever was longer) prior to first study drug administration
- use of any alkalinizing agents within 30 days prior to first study drug administration
- individuals having undergone any major surgery within 6 months prior to start of study, unless deemed not clinically significant by PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Randomized, Double-Blind, Active-Controlled, 2-Treatment, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Abuse Liability of Dextroamphetamine Sulfate From an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
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.
Read the detailed description
VAL-103 is a phase 1, pilot, randomized, double-blind, active-controlled, 2-treatment crossover study. The study objectives include assessing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of manipulated ADAIR 30 mg compared to crushed d-amphetamine sulfate IR 30 mg (DEX) administered IN in non-dependent recreational stimulant users. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.
A total of 16 qualified subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests, and Columbia Suicide Severity Rating Scale (C-SSRS).
- Conditions
- ADHD, Narcolepsy
- Being tested
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAIR 10mg IR capsulesDrug
manipulated ADAIR IR 3x10 mg capsules
Crushed d-amphetamine sulfate IR tabletsDrug
crushed d-amphetamine sulfate IR 6 x 5 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | crushed d-amphetamine IR tablets Receives: Drug: ADAIR 10mg IR capsules; Drug: Crushed d-amphetamine sulfate IR tablets |
| Treatment B | Experimental | manipulated ADAIR IR capsules Receives: Drug: ADAIR 10mg IR capsules; Drug: Crushed d-amphetamine sulfate IR tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse event reporting
Assess the safety and tolerability as measured by the incidence, frequency, and severity of treatment-emergent adverse events
Measured: Day 1 to Day 9 (Treatment Phase)
Abnormal Vital Signs
Number and percent of subjects with abnormal vital sign values
Measured: Day 1 to Day 9 (Treatment Phase)
Abnormal ECG Values
Number and percent of abnormal ECG values
Measured: Day 1 to Day 9 (Treatment Phase)
Abnormal clinical laboratory results
Number and percent of abnormal clinical laboratory results
Measured: Day 1 to Day 9 (Treatment Phase)
Secondary outcomes (15)
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration
Measured: Up to 24 hours post dose
Time to Maximum Plasma Concentration (tmax)
Time to maximum plasma concentration
Measured: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-1h
Area under the plasma concentration vs time curve from time 0 to 1 hour (AUC 0-1h)
Measured: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-2h
Area under the plasma concentration vs time curve from time 0 to 2 hours (AUC0-2h)
Measured: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-4h
Area under the plasma concentration vs time curve from time 0 to 4 hours (AUC0-4h)
Measured: Up to 24 hours post dose
Area Under the Plasma Concentration AUCt
Area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration, or last sampling time t (AUCt)
Measured: Up to 24 hours post dose
Area Under the Plasma Concentration AUCinf
Area under the plasma concentration vs time curve extrapolated to infinity (AUCinf)
Measured: Up to 24 hours post dose
Abuse quotient (AQ)
Abuse quotient (AQ): Cmax/tmax
Measured: Up to 24 hours post dose
Terminal elimination rate constant λz
Terminal elimination rate constant (λz)
Measured: Up to 24 hours post dose
Terminal elimination half-life t½
Terminal elimination half-life (t½)
Measured: Up to 24 hours post dose
Bipolar Ease of Snorting visual analog scale (VAS)
Bipolar Ease of Snorting VAS minimum (peak) effect (Emin)
Measured: Up to 24 hours post dose
Bipolar Likeability of Snorting VAS
Bipolar Likeability of Snorting VAS -minimum (peak) effect (Emin), maximum (peak) effect (Emax), time-averaged area under the effect curve from time 0 to 24 hours postdose (TA_AUE)
Measured: Up to 24 hours post dose
Bipolar Comfort of Snorting VAS
Bipolar Comfort of Snorting VAS - minimum (peak) effect (Emin), maximum (peak) effect (Emax), time-averaged area under the effect curve from time 0 to 24 hours postdose (TA_AUE)
Measured: Up to 24 hours post dose
Subject-Rated Assessment of Intranasal Irritation (SRAII)
Subject-Rated Assessment of Intranasal Irritation (SRAII) - maximum (peak) effect (Emax)and TEmax: time to maximum effect)
Measured: Up to 24 hours post dose
Percent of dose insufflated
Percent of dose insufflated
Measured: 0 min (dosing time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start27 May 2019
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vallon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Whitaker, MD, Study director, Vallon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232644
- Sponsor's protocol ID
- VAL-103
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Double-Blind, Active-Controlled, 2-Treatment, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Abuse Liability of Dextroamphetamine Sulfate From an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
- ClinicalTrials.gov ID
- NCT04232644
- Acronym / sponsor ID
- VAL-103
- Conditions
- ADHD, Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vallon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2019 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
VAL-103 is a phase 1, pilot, randomized, double-blind, active-controlled, 2-treatment crossover study. The study objectives include assessing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of manipulated ADAIR 30 mg compared to crushed d-amphetamine sulfate IR 30 mg (DEX) administered IN in non-dependent recreational stimulant users. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.
A total of 16 qualified subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests, and Columbia Suicide Severity Rating Scale (C-SSRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: ADAIR 10mg IR capsules, Drug: Crushed d-amphetamine sulfate IR tabletscrushed d-amphetamine IR tablets |
| Treatment B | Experimental | Drug: ADAIR 10mg IR capsules, Drug: Crushed d-amphetamine sulfate IR tabletsmanipulated ADAIR IR capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAIR 10mg IR capsulesmanipulated ADAIR IR 3x10 mg capsules | Drug | Treatment A, Treatment B |
| Crushed d-amphetamine sulfate IR tabletscrushed d-amphetamine sulfate IR 6 x 5 mg tablets | Drug | Treatment A, Treatment B |
Primary outcome
Treatment-emergent adverse event reporting
Time frame: Day 1 to Day 9 (Treatment Phase)
Assess the safety and tolerability as measured by the incidence, frequency, and severity of treatment-emergent adverse events
Abnormal Vital Signs
Time frame: Day 1 to Day 9 (Treatment Phase)
Number and percent of subjects with abnormal vital sign values
Abnormal ECG Values
Time frame: Day 1 to Day 9 (Treatment Phase)
Number and percent of abnormal ECG values
Abnormal clinical laboratory results
Time frame: Day 1 to Day 9 (Treatment Phase)
Number and percent of abnormal clinical laboratory results
15 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Up to 24 hours post dose
Time to Maximum Plasma Concentration (tmax)
Time frame: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-1h
Time frame: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-2h
Time frame: Up to 24 hours post dose
Area Under the Plasma Concentration AUC0-4h
Time frame: Up to 24 hours post dose
Area Under the Plasma Concentration AUCt
Time frame: Up to 24 hours post dose
Area Under the Plasma Concentration AUCinf
Time frame: Up to 24 hours post dose
Abuse quotient (AQ)
Time frame: Up to 24 hours post dose
Terminal elimination rate constant λz
Time frame: Up to 24 hours post dose
Terminal elimination half-life t½
Time frame: Up to 24 hours post dose
Bipolar Ease of Snorting visual analog scale (VAS)
Time frame: Up to 24 hours post dose
Bipolar Likeability of Snorting VAS
Time frame: Up to 24 hours post dose
Bipolar Comfort of Snorting VAS
Time frame: Up to 24 hours post dose
Subject-Rated Assessment of Intranasal Irritation (SRAII)
Time frame: Up to 24 hours post dose
Percent of dose insufflated
Time frame: 0 min (dosing time)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Whitaker, MD study director
Vallon Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADAIR 10mg IR capsules and Crushed d-amphetamine sulfate IR tablets in people with ADHD and Narcolepsy, run by Vallon Pharmaceuticals, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse event reporting (time frame: Day 1 to Day 9 (Treatment Phase)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.