Loading clinical trials...

A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT07465731•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

•1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
•2. 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.
•3. Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
•4. 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.
•5. History of any significant drug allergy or known or suspected hypersensitivity.
•6. Any participant who, in the opinion of the investigator, should not participate in the trial.

Locations (1)

ICON, plc.,

Lenexa, Kansas, United States

Key Dates

Start Date

October 27, 2022

Primary Completion Date

March 26, 2023

Completion Date

March 26, 2023

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Healthy Volunteers

Interventions

Centanafadine SR

DRUG

Centanafadine QD XR

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study of ENX-104 in Healthy Participants

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Single-dose,First-in-human of KLA478