Skip to main content
OpenTrials
Completed

NCT Number: NCT07253441

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Lenexa, Lenexa, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
  • In good health as determined by:
  • Medical history
  • Physical examination
  • Electrocardiogram (ECG)
  • Serum/urine chemistry, hematology, and serology tests.
  • 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

  • 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.
  • History of drug and/or alcohol abuse within 2 years prior to screening.
  • 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.
  • History of any significant drug allergy or known or suspected hypersensitivity.
  • 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.
  • Any participant who, in the opinion of the investigator, should not participate in the trial.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Treatment and study plan

CTN XR (TBM)

Drug

Oral capsules

Other names: EB-1020

CTN SR

Drug

Oral tablets

Other names: EB-1020

CTN XR (Clin)

Drug

Oral capsules

Other names: EB-1020

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Cohort 5: Cmax of CTN

    Time frame: Up to Day 11

  5. 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

  6. 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

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

    Time frame: Up to Day 11

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Cohort 5: Tmax of CTN and its Metabolites

    Time frame: Up to Day 11

  8. Cohort 5: CL/F of CTN

    Time frame: Up to Day 11

  9. 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

  10. 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

  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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Multiple-arm, Phase 1, Open-label Trial to Determine Dose Strength Equivalence and Effect of Food on To-Be-Marketed Centanafadine QD XR Capsules, Bioequivalence Between Clinical and To-Be-Marketed QD XR Capsules and Relative Bioavailability of To-Be-Marketed QD XR Capsules to SR Tablets in Healthy Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.