Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Healthy Volunteers
Brief summary
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.
Interventions
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive). 2. In good health as determined by: * Medical history * Physical examination * Electrocardiogram (ECG) * Serum/urine chemistry, hematology, and serology tests. 3. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the investigator, to comply with all the requirements of the trial.
Exclusion criteria
1. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy. 2. History of drug and/or alcohol abuse within 2 years prior to screening. 3. History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies. 4. History of any significant drug allergy or known or suspected hypersensitivity. 5. A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site. 6. Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve Calculated From Time 0 to Time t (AUCt) of CTN | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of CTN | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohort 5: Cmax of CTN | Up to Day 11 |
| Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR | Up to Day 11 |
| Cohort 5: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of CTN SR | 24 Hours postdose up to Day 10 |
| Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN | Up to Day 11 |
Secondary
| Measure | Time frame |
|---|---|
| Cohorts 1, 2, 3, and 4: Percentage (%) Extrapolated AUC of CTN and its Metabolites | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohorts 1, 2, 3, and 4: AUC0-24h of CTN and its Metabolites | Cohorts 1 and 2: 24 Hours Postdose up to Day 4; Cohorts 3 and 4: 24 Hours Postdose up to Day 10 |
| Cohort 1, 2, 3, and 4: Time to Maximum (peak) Plasma Concentration (tmax) of CTN and its Metabolites | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohort 5: Tmax of CTN and its Metabolites | Up to Day 11 |
| Cohort 1, 2, 3, and 4: Volume of Distribution (Vz/F) of CTN | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohort 1, 2, 3, and 4: Terminal Phase Elimination Half-Life (t1/2,z) of CTN and its Metabolites | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohort 1, 2, 3, and 4: Apparent Clearance (CL/F) of CTN and its Metabolites | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12 |
| Cohort 5: CL/F of CTN | Up to Day 11 |
| All Cohorts: Number of Participants With Adverse Events (AEs) | Cohorts 1 and 2: Up to Day 11; Cohorts 3, 4, and 5: Up to Day 17 |
| All Cohorts: Number of Participants With Potentially Clinically Relevant Laboratory Tests | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11 |
| All Cohorts: Number of Participants With Potentially Clinically Relevant Vital Signs | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11 |
| All Cohorts: Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Tests | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11 |
| All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11 |
Countries
United States
Outcome results
None listed