NCT07253441

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

August 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 19, 2025

Last Update Submit

December 4, 2025

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

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

    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

    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

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

  • Cohort 5: Cmax of CTN

    Up to Day 11

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

    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

    24 Hours postdose up to Day 10

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

    Up to Day 11

Secondary Outcomes (13)

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

    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

    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

    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

    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

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

  • +8 more secondary outcomes

Study Arms (14)

Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules

EXPERIMENTAL

Participants first receive a 1 × 328.8 mg CTN capsule, orally, on Day 1. Then, they receive 2 × 164.4 mg CTN capsules, orally, on Day 4.

Drug: CTN XR (TBM)

Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules

EXPERIMENTAL

Participants first receive 2 × 164.4 mg CTN capsules, orally, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, on Day 4.

Drug: CTN XR (TBM)

Cohort 2: CTN Fasted State, Then CTN Fed state

EXPERIMENTAL

Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fasted state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fed state, on Day 4.

Drug: CTN XR (TBM)

Cohort 2: CTN Fed state, Then CTN Fasted state

EXPERIMENTAL

Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fed state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fasted state, on Day 4.

Drug: CTN XR (TBM)

Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR

EXPERIMENTAL

Participants first receive CTN 200 mg SR, tablets, orally on Day 1 followed by CTN 164.4 mg XR, capsules, orally on Day 4. Participants then receive CTN 400 mg SR, tablets, orally on Day 7, followed by CTN 328.8 mg XR, capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR

EXPERIMENTAL

Participants first receive CTN 164.4 mg XR, capsules, orally on Day 1 followed by CTN 200 mg SR, tablets, orally on Day 4. Participants then receive CTN 328.8 mg XR, capsules, orally on Day 7, followed by CTN 400 mg SR, tablets, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR

EXPERIMENTAL

Participants first receive CTN 400 mg SR, tablets, orally on Day 1 followed by CTN 328.8 mg XR, capsules, orally on Day 4. Participants then receive CTN 200 mg SR, tablets, orally on Day 7, followed by CTN 164.4 mg XR, capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR

EXPERIMENTAL

Participants first receive CTN 328.8 mg XR, capsules, orally on Day 1 followed by CTN 400 mg SR, tablets, orally on Day 4. Participants then receive CTN 164.4 mg XR, capsules, orally on Day 7, followed by CTN 200 mg SR, tablets, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM)

EXPERIMENTAL

Participants first receive CTN 164.4 mg XR (Clin), capsules, orally on Day 1 followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (Clin), capsules, orally on Day 7, followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN XR (Clin)

Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin)

EXPERIMENTAL

Participants first receive CTN 164.4 mg XR (TBM), capsules, orally on Day 1 followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (TBM), capsules, orally on Day 7, followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN XR (Clin)

Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM)

EXPERIMENTAL

Participants first receive CTN 328.8 mg XR (Clin), capsules, orally on Day 1 followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (Clin), capsules, orally on Day 7, followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN XR (Clin)

Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin)

EXPERIMENTAL

Participants first receive CTN 328.8 mg XR (TBM), capsules, orally on Day 1 followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (TBM), capsules, orally on Day 7, followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 10.

Drug: CTN XR (TBM)Drug: CTN XR (Clin)

Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR

EXPERIMENTAL

Participants first receive CTN 328.8 mg XR (TBM), capsules, orally, once a day (QD) from Day 1 to Day 5. Then, they receive CTN 400 mg SR, tablets, orally, from Day 6 to Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM)

EXPERIMENTAL

Participants first receive CTN 400 mg SR, tablets, orally from Day 1 to Day 5. Then, they will receive CTN 328.8 mg XR (TBM), capsules, orally, QD from Day 6 to Day 10.

Drug: CTN XR (TBM)Drug: CTN SR

Interventions

CTN XR (TBM)DRUG

Oral capsules

Also known as: EB-1020
Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsulesCohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsulesCohort 2: CTN Fasted State, Then CTN Fed stateCohort 2: CTN Fed state, Then CTN Fasted stateCohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SRCohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XRCohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SRCohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XRCohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM)Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin)Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM)Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin)Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SRCohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM)
CTN SRDRUG

Oral tablets

Also known as: EB-1020
Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SRCohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XRCohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SRCohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XRCohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SRCohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM)
CTN XR (Clin)DRUG

Oral capsules

Also known as: EB-1020
Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM)Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin)Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM)Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

ICON Salt Lake City

Millcreek, Utah, 84124, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

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

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

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

November 19, 2025

First Posted

November 28, 2025

Study Start

August 29, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

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(2)