NCT07465731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (6)

Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR

EXPERIMENTAL

Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4.

Drug: Centanafadine SRDrug: Centanafadine QD XR

Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR

EXPERIMENTAL

Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4.

Drug: Centanafadine SRDrug: Centanafadine QD XR

Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR

EXPERIMENTAL

Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4.

Drug: Centanafadine SRDrug: Centanafadine QD XR

Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR

EXPERIMENTAL

Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4.

Drug: Centanafadine SRDrug: Centanafadine QD XR

Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed

EXPERIMENTAL

Participants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4.

Drug: Centanafadine QD XR

Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted

EXPERIMENTAL

Participants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4.

Drug: Centanafadine QD XR

Interventions

Centanafadine SRDRUG

Oral tablets.

Also known as: EB-1020
Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SRArm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XRArm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SRArm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR
Centanafadine QD XRDRUG

Oral capsules.

Also known as: EB-1020
Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SRArm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XRArm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SRArm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XRArm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR FedArm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON, plc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

October 27, 2022

Primary Completion

March 26, 2023

Study Completion

March 26, 2023

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
More information

Locations

US(1)