A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

Otsuka Pharmaceutical Development & Commercialization, Inc.174 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

CTN XR (TBM)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN

Time frame: 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

Time frame: 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

Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohort 5: Cmax of CTN

Time frame: Up to Day 11

Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR

Time frame: 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

Time frame: 24 Hours postdose up to Day 10

Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN

Time frame: Up to Day 11

Secondary Outcomes

Cohorts 1, 2, 3, and 4: Percentage (%) Extrapolated AUC of CTN and its Metabolites

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohort 1, 2, 3, and 4: Volume of Distribution (Vz/F) of CTN

Time frame: 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

Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohort 5: Tmax of CTN and its Metabolites

Time frame: Up to Day 11

Cohort 5: CL/F of CTN

Time frame: Up to Day 11

All Cohorts: Number of Participants With Adverse Events (AEs)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11

A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes