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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Amphetamine Extended Release Suspension [Dyanavel]
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Patients (AMPH EROS)
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All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base

Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Study Patients (AMPH EROS)
Hide Arm/Group Description

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

Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

Overall Number of Baseline Participants 5
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Intention to treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
4  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female 2
Male 3
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
2
  40.0%
Not Hispanic or Latino
3
  60.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 3
White 2
More than one race 0
Unknown or Not Reported 0
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 5 participants
16.2  (1.1)
1.Primary Outcome
Title Plasma Concentrations of d- and L-amphetamine
Hide Description Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Time Frame 0-28 hours postdose
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Hide Analysis Population Description
intention to treat population
Arm/Group Title Plasma Concentration of d-Amphetamine Plasma Concentration of l-Amphetamine
Hide Arm/Group Description:

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

Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

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

Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

Overall Number of Participants Analyzed 5 5
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
0 hours postdose 0  (0) 0  (0)
1 hour postdose 3.5  (3.0) 1.1  (0.9)
3 hours postdose 19.9  (2.2) 6.2  (0.7)
4 hours postdose 20.2  (2.5) 6.4  (0.8)
6 hours postdose 17.5  (3.2) 5.7  (1.1)
8 hours postdose 16.9  (2.2) 5.6  (0.8)
10 hours postdose 14.4  (3.3) 4.8  (1.1)
12 hours postdose 11.6  (3.2) 3.9  (1.1)
28 hours postdose 2.2  (0.7) 0.9  (0.2)
Time Frame 48 hours post-dose. Pharmacokinetics study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Patients (AMPH EROS)
Hide Arm/Group Description

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

Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis

All-Cause Mortality
Study Patients (AMPH EROS)
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Study Patients (AMPH EROS)
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Study Patients (AMPH EROS)
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Antonio Pardo MD
Organization: Tris Pharma, Inc.
Phone: 16107502210
EMail: apardo@trispharma.com
Layout table for additonal information
Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03610464     History of Changes
Other Study ID Numbers: TRI102-PPK-300
First Submitted: July 23, 2018
First Posted: August 1, 2018
Results First Submitted: May 16, 2019
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019