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

NCT03610464 | Completed Phase 4 Results FDA Drug

• 1 other identifier: TRI102-PPK-300
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of d- and L-amphetamine

  Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.

  0-28 hours postdose

Study Arms (1)

Study patients (AMPH EROS)

EXPERIMENTAL

All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base

Drug: Amphetamine Extended Release Suspension [Dyanavel]

Interventions

Amphetamine Extended Release Suspension [Dyanavel] DRUG

1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

Also known as: DYANAVEL XR, amphetamine extended release oral suspension

Study patients (AMPH EROS)

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female aged 4 to 5 years at the time of enrollment into this study;
• Body weight ≥ 28 lb. at screening visit;
• 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);
• Provide written informed consent (parent/guardian) prior to participation in the study.

You may not qualify if:

• 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
• 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
• 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)
• Clinically significant (CS) abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
• 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);
• 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);
• Use of atomoxetine within 14 days of dosing
• 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
• Abnormal CS laboratory test value at screening that, in the opinion of the sponsor or medical monitor, would preclude study participation
• Known history of allergy/hypersensitivity to amphetamine or any of the components of AMPH EROS, heparin flush and topical anesthetics
• Parent or guardian's inability or unwillingness to follow directions of the Investigator or study research staff

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (1)

Meridien Research, Inc.

Maitland, Florida, 32751, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Antonio Pardo MD
• Organization: Tris Pharma, Inc.

apardo@trispharma.com

16107502210

Study Officials

• Antonio Pardo, MD

  Tris Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: May 7, 2018
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)