Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Amphetamine Extended Release Suspension [Dyanavel]
Intervention description: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
Intervention MeSH terms: Amphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This was an open-label, single-site, single-dose one-period, one-treatment study in 5 pediatric subjects diagnosed with ADHD, otherwise healthy. Subjects received a single, 1 mL dose of AMPH EROS 2.5 mg/mL, from which PK was assessed over a 28 hour period.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study was to evaluate the plasma amphetamine concentration/time profile
      of amphetamine extended release oral suspension in children aged 4 to 5 years with
      attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine
      extended release oral suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 4 to 5 years at the time of enrollment into this study;

          2. Body weight ≥ 28 lb. at screening visit;

          3. Diagnosed with ADHD by a psychiatrist, psychologist, developmental pediatrician,
             pediatrician, or an experienced licensed allied health professional approved by the
             Sponsor by using the DSM-5 criteria and supported by a structured Kiddie-Schedule for
             Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL)
             interview, administered at the Screening Visit (Visit 0);

          4. Provide written informed consent (parent/guardian) prior to participation in the
             study.

        Exclusion Criteria:

          1. Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of
             specific phobias, learning disorders, motor skills disorders, communication
             disorders,oppositional defiant disorder, elimination disorders, and sleep disorders

          2. History of chronic medical illnesses including seizure disorder (excluding a history
             of febrile seizures), moderate to severe hypertension, untreated thyroid disease,
             known structural cardiac disorders, serious cardiac conditions, serious arrhythmias,
             cardiomyopathy and known family history of sudden death

          3. Known history or presence of significant renal or hepatic disease, as indicated by
             clinical laboratory assessment (liver function test results ≥ 2 times the upper limit
             of normal, blood urea nitrogen, or creatinine)

          4. Clinically significant (CS) abnormal ECG or cardiac findings on physical examination
             (including the presence of a pathologic murmur)

          5. Use of the following medications within 30 days of dosing:

               -  MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine,
                  tranylcypromine);

               -  Tricyclic Antidepressants (e.g. Desipramine, protriptyline);

          6. Use of the following medications within 3 days of dosing

               -  Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid
                  HCl, ascorbic acid);

               -  Urinary acidifying agents (e.g., ammonium chloride, sodium acid
                  phosphate,methenamine salts);

          7. Use of atomoxetine within 14 days of dosing

          8. Planned use of prohibited drugs or agents from the screening visit through the end of
             the study. Medications used to support sleep may be acceptable with the written
             approval of the sponsor or medical monitor

          9. Abnormal CS laboratory test value at screening that, in the opinion of the sponsor or
             medical monitor, would preclude study participation

         10. Known history of allergy/hypersensitivity to amphetamine or any of the components of
             AMPH EROS, heparin flush and topical anesthetics

         11. Parent or guardian's inability or unwillingness to follow directions of the
             Investigator or study research staff

         12. Any uncontrolled medical condition that in the opinion of the Investigator would
             preclude study participation

         13. History of significant illness requiring hospitalization, or surgery requiring
             anesthetics within 30 days of dosing.