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Healthy volunteers help Fine-Tune ADHD drug absorption

NCT ID NCT07253441

Knowledge-focused Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested how different capsule versions of the ADHD drug centanafadine are absorbed in the body. 174 healthy adults took part to see if a single high-dose capsule works the same as two lower-dose capsules, and whether food changes absorption. No treatment was given; the goal was to gather information for future manufacturing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

174 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Body mass index (BMI) between 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 investigator, to comply with all the requirements of the trial. Exclusion Criteria: 1. 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. 2. History of drug and/or alcohol abuse within 2 years prior to screening. 3. 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. 4. History of any significant drug allergy or known or suspected hypersensitivity. 5. 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. 6. Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit disorder with hyperactivity

Contacts and locations

Locations

  • ICON Lenexa

    Lenexa, Kansas, 66219, United States

  • ICON Salt Lake City

    Millcreek, Utah, 84124, United States

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