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Experimental brain drug TAK-935 put to the test in healthy volunteers

NCT ID NCT04461483

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called TAK-935 in healthy Japanese adults to see how the body processes it and whether it is safe. The study gives single rising doses to one group and multiple doses with gradual increases to another. Participants receive either TAK-935 or a placebo, and researchers track side effects and drug levels in the blood. The goal is to understand the drug's basic behavior before it can be tested in patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-935, an experimental drug taken as tablets
What this could lead to
If TAK-935 proves safe and well tolerated, researchers could move it into larger trials for conditions linked to brain signaling, such as epilepsy or other neurological disorders.
What could go wrong
This is a small, early-stage study in healthy volunteers, so it cannot show whether the drug works for any disease. Side effects may appear that stop further testing, and results in Japanese participants may not apply to other groups.

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

33 people

The number who actually took part.

Started

Aug 2020

Finished

Nov 2020

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

20 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. The participant must understand the study procedures and agree to participate by providing written informed consent. 2. The participant must be willing and able to comply with all study procedures and restrictions. 3. The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent. 4. The participant must have a body mass index (BMI) \>=18.5 and =\<25.0 kg/m\^2 at the Screening Visit. 5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure. 6. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening Visit and prior to the first dose of study drug. 7. The participant must meet the following birth control requirements: * Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until 90 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided the participant is at least 1-year postbilateral vasectomy procedure prior to the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year prior to the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedure should be provided. * Is a male participant who agrees to not donate sperm from the first dose of study drug until 90 days after the last dose of study drug. * Is a female participant of nonchildbearing potential, defined by at least 1 of the following criteria: 1. Postmenopausal (defined as 12 months of spontaneous amenorrhea in females aged \>45 years or \>=6 months of spontaneous amenorrhea in females aged \>45 years with serum follicle-stimulating hormone \[FSH\] levels \>40 mIU/mL). Appropriate documentation of follicle-stimulating hormone levels should be required. 2. Hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure. 3. Had a tubal ligation with appropriate documentation of surgical procedure. 4. Congenital conditions such as uterine aplasia etc. Exclusion Criteria: 1. Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular (including arrhythmia), hematological, hepatic, immunological, renal, respiratory, genitourinary, major neurological (including stroke, epileptic seizure), or degenerative ophthalmological abnormalities or diseases 2. Has participated in another investigational trial within 4 weeks or 5 half-lives (whichever is longer) before the pretrial visit (Screening). The 4-week or 5 half-lives window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial. 3. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor. 4. Has a history of cancer (malignancy). 5. Has any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within 12 months, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS) or is clinically judged by the investigator to be at risk for suicide. 6. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food. 7. Has a positive alcohol or drug screen. 8. Had major surgery, donated or lost whole blood prior to the start of study drug administration as any of below: For both male and female participants, \>=200 mL within 4 weeks (28 days) For male participants, \>=400 mL within 12 weeks (84 days), \>=800 mL in total within 52 weeks (364 days) For female participants, \>=400 mL within 16 weeks (112 days). \>=400 mL in total within 52 weeks (364 days) 9. Had gastrointestinal surgery that could impact the absorption of study drug. 10. Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria. 11. Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds. 12. Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of study drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit. 13. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 14. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. 15. Has a substance abuse disorder. 16. Has a QTcF \>450 msec confirmed with one repeat testing, at the Screening Visit. 17. Had abnormal Screening or Day -1 laboratory values that suggested a clinically significant underlying disease or participant with the following laboratory abnormalities: ALT and/or AST \>1.5 time ULN. 18. Has tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody/antigen, or serologic reactions for syphilis at Screening. 19. In the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, Japan

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