Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)

At a single US-based study site, a driving simulation will be used to assess the effect on driving performance for the co-primary endpoints, study subjects' driving performance at 45 minutes and 10 hours post-dose, compared with placebo. Eligible subjects will be prescreened for ADHD but otherwise healthy, aged 18-25 years.

Driving simulations that simulate common driving events to which the study subject must react. The reactions to each event will be assessed. Using a parallel-group design, subjects will be assessed while on study drug, and while on placebo.

Safety assessments will include spontaneously reported treatment-emergent adverse events and vital signs at 4 hours post-dose.

Inclusion criteria

• Males or females aged 18 to 25 years, inclusive, at the time of screening who have a valid driver's license.
• Normal visual acuity (either uncorrected or corrected with glasses, contact lenses or surgery) at Screening based upon clinical assessment of the Investigator
• Diagnosed with ADHD using the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) criteria based on ADHD module from the Mini-International Neuropsychiatric Interview (M.I.N.I) version 7.0.2.
• IQ within normal range based upon clinical assessment of the Investigator.
• For female participants, presently using an acceptable method of contraception based upon clinical assessment of the Investigator.
• Willing to abstain from using any forms of cannabinoids (THC, CBD, hemp oil, etc.) for 2 weeks prior to the Driving Simulation Visit (if applicable).
• Be able to understand, read, write, and speak English fluently to complete the study related materials.
• Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion criteria

• Current or lifetime history of bipolar disorder or any psychotic disorder.
• Current active symptoms of major depression generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder based upon clinical assessment of the Investigator.
• Known history of chronic medical illnesses including known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, and known family history of sudden death.
• History of uncontrolled hypertension or a resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg. Patients with well-controlled hypertension on a stable dose for at least 3 months of anti-hypertensives will be allowed to participate.
• Have clinically significant findings in vital signs measurements at Screening including:

• Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg (average of triplicate measurements)
• Heart rate >100 bpm (average of triplicate measurements)
• Known history or presence of significant renal or hepatic disease.
• Use of monoamine oxidase inhibitors (MAOI), e.g. selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue, within 14 days of the Driving Simulator Visit.
• Use of ADHD medications including all stimulants (methylphenidate, amphetamine or derivatives of any of these products), within 48 hours of the Driving Simulator Visit.
• Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
• Known history of allergy/hypersensitivity to amphetamine or any of the components of the test products.
• Known history of lack of clinical response to amphetamine based upon Investigator assessment
• Any uncontrolled medical condition that, in the opinion of Medical Monitor or Sponsor, would preclude study participation.
• History or presence of alcohol dependence or substance abuse disorder or within the last 6 months based upon clinical assessment of the Investigator.
• Positive urine pregnancy test at Driving Simulator Visit
• Positive breath alcohol test at Driving Simulator Visit.
• Patient's inability or unwillingness to follow directions from the study research staff.