This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.
This is a single dose crossover study. Participants in each arm will receive 3 treatments in a 3 -sequence, 3-period, crossover design. In each arm, participants will be randomized to 1 of 3 treatment sequences: Sequence 1: ABC, Sequence 2: BCA, or Sequence 3: CAB. Here's what each treatment incudes: * Treatment A - centanafadine alone in both Arms 1 and 2. * Treatment B - methylphenidate alone in Arm 1 and lisdexamfetamine alone in Arm 2. * Treatment C - centanafadine combined with methylphenidate in Arm 1, and centanafadine combined with lisdexamfetamine in Arm 2. The duration of trial participation for each participant will be approximately 44 days, and the overall trial duration is expected to be approximately 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Oral, QD XR capsules.
Oral tablets.
Oral capsules
ICON
Salt Lake City, Utah, United States
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Time frame: Baseline, Day 12 or ET
Change from Baseline in Heart Rate (HR) at Day 12 or ET
Time frame: Baseline, Day 12 or ET
Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Area under the concentration time curve from time zero to the time of the last observable concentration at time (AUC0-12 hours) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Area under the concentration time curve from time zero to infinity (AUC-inf) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time to maximum (peak) Plasma Concentration (Tmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Terminal phase elimination half-life (t1/2,z) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Volume of distribution following extravascular administration (Vz/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
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Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Apparent clearance of drug from plasma after extravascular administration (CL/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose