ADHD
Conditions
Keywords
Attention-deficit/hyperactivity disorder, Healthy Adults
Brief summary
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.
Detailed description
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.
Interventions
DRUGCentanafadine
Oral, QD XR capsules.
DRUGMethylphenidate
Oral tablets.
DRUGLisdexamfetamine
Oral capsules
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2). * Must be in good health, based on: * Medical history * Physical examination * Heart test (Electrocardiogram \[ECG\]) * Lab tests (blood, urine and other routine checks) * Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety. * Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.
Exclusion criteria
* History of drug and/or alcohol abuse in past 2 years. * History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies. * Known drug allergy or hypersensitivity. * Any history of significant bleeding problems. * Difficulty donating blood in the past. * Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine. * Uncontrolled high blood pressure (BP) (systolic blood pressure \[SBP\] \> 140 millimeters of mercury (mmHg) or diastolic blood pressure \[DBP\] \> 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing). * History of unexplained fainting (syncope). * Serious mental health disorders that could interfere with participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET) | Baseline, Day 12 or ET |
| Change from Baseline in Heart Rate (HR) at Day 12 or ET | Baseline, Day 12 or ET |
Secondary
| Measure | Time frame |
|---|---|
| Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine | 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 | 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 | 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 | 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 | 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 | 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 | Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose |
Countries
United States
Outcome results
None listed