Trial Outcomes & Findings for Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years (NCT NCT03610464)

NCT ID: NCT03610464

Last Updated: 2019-06-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 0-28 hours postdose
• Results posted on: 2019-06-25

Participant Flow

Participant milestones

Measure	Study Patients (AMPH EROS) 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 Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Patients (AMPH EROS) n=5 Participants 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
Age, Continuous	4 Years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	16.2 kg/m^2 STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 0-28 hours postdose

Population: intention to treat population

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

Outcome measures

Measure	Plasma Concentration of d-Amphetamine n=5 Participants 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	Plasma Concentration of l-Amphetamine n=5 Participants 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
Plasma Concentrations of d- and L-amphetamine 0 hours postdose	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0
Plasma Concentrations of d- and L-amphetamine 1 hour postdose	3.5 ng/mL Standard Deviation 3.0	1.1 ng/mL Standard Deviation 0.9
Plasma Concentrations of d- and L-amphetamine 3 hours postdose	19.9 ng/mL Standard Deviation 2.2	6.2 ng/mL Standard Deviation 0.7
Plasma Concentrations of d- and L-amphetamine 4 hours postdose	20.2 ng/mL Standard Deviation 2.5	6.4 ng/mL Standard Deviation 0.8
Plasma Concentrations of d- and L-amphetamine 6 hours postdose	17.5 ng/mL Standard Deviation 3.2	5.7 ng/mL Standard Deviation 1.1
Plasma Concentrations of d- and L-amphetamine 8 hours postdose	16.9 ng/mL Standard Deviation 2.2	5.6 ng/mL Standard Deviation 0.8
Plasma Concentrations of d- and L-amphetamine 10 hours postdose	14.4 ng/mL Standard Deviation 3.3	4.8 ng/mL Standard Deviation 1.1
Plasma Concentrations of d- and L-amphetamine 12 hours postdose	11.6 ng/mL Standard Deviation 3.2	3.9 ng/mL Standard Deviation 1.1
Plasma Concentrations of d- and L-amphetamine 28 hours postdose	2.2 ng/mL Standard Deviation 0.7	0.9 ng/mL Standard Deviation 0.2

Adverse Events

Study Patients (AMPH EROS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonio Pardo MD

Tris Pharma, Inc.

Phone: 16107502210

Email: apardo@trispharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place