Healthy Volunteers
Conditions
Brief summary
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
Interventions
DRUGCentanafadine SR
Oral tablets.
DRUGCentanafadine QD XR
Oral capsules.
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 from 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 principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). 2. 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. 3. Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing. 4. History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies. 5. History of any significant drug allergy or known or suspected hypersensitivity. 6. Any participant who, in the opinion of the investigator, should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine | Up to Day 6 |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine | Up to Day 6 |
| Maximum Plasma Concentration (Cmax) of Centanafadine | Up to Day 6 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Centanafadine | Up to Day 6 |
| Terminal-phase Eimination Half-life (T1/2z) of Centanafadine | Up to Day 6 |
| Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine | Up to Day 6 |
| AUCt of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
| AUCinfinity of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
| Cmax of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
Countries
United States
Outcome results
None listed