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Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years

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ClinicalTrials.gov Identifier: NCT03610464
Recruitment Status : Completed
First Posted : August 1, 2018
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Tris Pharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Amphetamine Extended Release Suspension [Dyanavel] Phase 4

Detailed Description:

DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base (amphetamine extended-release oral suspension; AMPH EROS). Drug-resin complexation is formed with the amphetamine and sodium polystyrene sulfonate, an ion exchange resin. The extended release feature of the product is achieved by coating a portion of the drug/resin complexes with an extended release coating. AMPH EROS contains approximately a 3.2:1 ratio of d-amphetamine compared to l-amphetamine.

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

These data will guide appropriate dosing in planned safety and efficacy studies with AMPH EROS in a preschool population with attention-deficit/hyperactivity disorder.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : May 23, 2018


Arm Intervention/treatment
Experimental: Study patients (AMPH EROS)
All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base
Drug: Amphetamine Extended Release Suspension [Dyanavel]
1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
Other Name: DYANAVEL XR, amphetamine extended release oral suspension




Primary Outcome Measures :
  1. Plasma Concentrations of d- and L-amphetamine [ Time Frame: 0-28 hours postdose ]
    Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610464


Locations
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United States, Florida
Meridien Research, Inc.
Maitland, Florida, United States, 32751
Sponsors and Collaborators
Tris Pharma, Inc.
Investigators
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Study Director: Antonio Pardo, MD Tris Pharma, Inc.
  Study Documents (Full-Text)

Documents provided by Tris Pharma, Inc.:

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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03610464     History of Changes
Other Study ID Numbers: TRI102-PPK-300
First Posted: August 1, 2018    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors