This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).
For additional information regarding sites, contact 844-687-8522
Little Rock, Arkansas, United States
For additional information regarding sites, contact 844-687-8522
Decatur, Georgia, United States
For additional information regarding sites, contact 844-687-8522
Las Vegas, Nevada, United States
For additional information regarding sites, contact 844-687-8522
Oklahoma City, Oklahoma, United States
Maximal peak plasma concentration (Cmax)
Time frame: 24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time frame: 24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time frame: 24 hours
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For additional information regarding sites, contact 844-687-8522
San Antonio, Texas, United States