Healthy Adult Participants
Conditions
Keywords
ADHD, Attention-deficit/hyperactivity disorder
Brief summary
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.
Interventions
DRUGCentanafadine
Centanafadine will be administered as an oral capsule.
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: 1. Medical history 2. Physical examination 3. Electrocardiogram (ECG) 4. 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 principal 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 investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. 2. History of drug and/or alcohol abuse within 2 years prior to screening. 3. History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies. 4. History of any significant drug allergy or known or suspected hypersensitivity. 5. Participants having taken an investigational drug within 30 days prior to screening. 6. Previous exposure to centanafadine. 7. Any history of significant bleeding or hemorrhagic tendencies. 8. A history of difficulty in donating blood. 9. The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP). 10. Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP. 11. 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 |
|---|---|
| Maximum Plasma Concentration (Cmax) of Centanafadine | Up to Day 5 |
| Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine | Up to Day 5 |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine | Up to Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine | Up to Day 5 |
| Percentage (%) of Extrapolated AUC of Centanafadine | Up to Day 5 |
| Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine | Up to Day 5 |
| Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine | Up to Day 5 |
Countries
United States
Outcome results
None listed