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OpenTrials
Completed

NCT Number: NCT07465731

A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine

The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON, plc.,

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index from 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 principal investigator, to comply with all the requirements of the trial.

Exclusion criteria

  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
  • 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.
  • Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
  • 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.
  • History of any significant drug allergy or known or suspected hypersensitivity.
  • Any participant who, in the opinion of the investigator, should not participate in the trial.

Treatment and study plan

Centanafadine SR

Drug

Oral tablets.

Other names: EB-1020

Centanafadine QD XR

Drug

Oral capsules.

Other names: EB-1020

Primary outcomes

  1. Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine

    Time frame: Up to Day 6

  2. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine

    Time frame: Up to Day 6

  3. Maximum Plasma Concentration (Cmax) of Centanafadine

    Time frame: Up to Day 6

Secondary outcomes

  1. Time to Maximum Plasma Concentration (Tmax) of Centanafadine

    Time frame: Up to Day 6

  2. Terminal-phase Eimination Half-life (T1/2z) of Centanafadine

    Time frame: Up to Day 6

  3. Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine

    Time frame: Up to Day 6

  4. AUCt of Centanafadine Under Fasted and Fed Conditions

    Time frame: Up to Day 6

  5. AUCinfinity of Centanafadine Under Fasted and Fed Conditions

    Time frame: Up to Day 6

  6. Cmax of Centanafadine Under Fasted and Fed Conditions

    Time frame: Up to Day 6

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label, Parallel-arm Trial to Assess Relative Bioavailability of Centanafadine Sustained-Release (SR) Tablet to Once-Daily Extended-Release (QD XR) Capsule Following Oral Administration in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

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.

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