A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 9, 2021

Primary Completion Date

April 26, 2023

Study Completion Date

April 26, 2023

Conditions
Attention-deficit Hyperactivity Disorder
Interventions
DRUG

Centanafadine

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).

Trial Locations (5)

30030

For additional information regarding sites, contact 844-687-8522, Decatur

72211

For additional information regarding sites, contact 844-687-8522, Little Rock

73106

For additional information regarding sites, contact 844-687-8522, Oklahoma City

78229

For additional information regarding sites, contact 844-687-8522, San Antonio

89128

For additional information regarding sites, contact 844-687-8522, Las Vegas

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT04786730 - A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder | Biotech Hunter | Biotech Hunter