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TAK-123 tested in healthy volunteers for safety

NCT ID NCT04155567

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a drug called TAK-123 in 10 healthy Japanese men to see how the body absorbs and processes it, and whether it causes any side effects. The drug was given as an infusion, and researchers measured levels of its components in the blood. Since this was a safety and pharmacokinetic study in healthy volunteers, it does not aim to treat any disease.

What this could mean

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

Active substance
TAK-123 (a combination of phenylacetate and benzoate)

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

10 people

The number who actually took part.

Started

Nov 2019

Finished

Dec 2019

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 45 years

Sex

Male participants only

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 is capable of understanding and complying with protocol requirements in the opinion of the investigator or sub-investigator. 2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures. 3. The participant is a Japanese healthy adult male. 4. The participant is aged 20 to 45 years inclusive at the time of informed consent. 5. The participant weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2), inclusive, at Screening. 6. The participant is sterile, vasectomized or agrees to use an appropriate method of contraception throughout the treatment period. Exclusion Criteria: 1. The participant has received any investigational drugs within 90 days before screening for this study (including the cases that at least 5 times the elimination half-lives of any investigational drugs have not yet passed). 2. The participant previously received TAK-123, its ingredients, or related compound before participation in this study except for the cases where benzoic acid is ingested as a food additive. 3. The participant is an employee of the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or who may be forced to provide consent. 4. The participants have previous or current history of diseases that may affect the participation in this study or study results, including uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine, hematologic, immune, skin disease or psychiatric disorder. 5. The participant has a history of multiple episodes or severe allergies (example, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription drugs, over-the-counter (OTC) drugs or foods. 6. The participant has had an anaphylactic reaction to active ingredients or additives of TAK-123, ondansetron or additives of ondansetron, or salicylic acid associated with the intravenous administration of TAK-123. 7. The participant has a positive urine drug test at the time of screening. 8. The participant has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study. 9. The participant consumes 6 or more servings of caffeinated beverages (containing about 720 milligram \[mg\] of caffeine or more) such as coffee, tea, cola, or energy drinks per day. 10. The participant is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the study drug administration. 11. The participant has a history of cancer. 12. The participant has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis. 13. The participant has poor peripheral venous access. 14. The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration. 15. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration. 16. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration. 17. The participant has any clinically relevant abnormality in vital signs or 12-lead electrocardiogram (ECG) at screening or predose of Day 1. 18. The participant has abnormal laboratory test values at screening indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 × upper limit of normal (ULN). 19. The participant has been on an abnormal diet (example, excessive drinking and eating or starvation condition) during the four weeks (28 days) prior to the start of the study drug administration in the opinion of the investigator or sub-investigator. 20. The participant who used or plans to use excluded concomitant medications, supplements, or dietary products during the predefined period in this study. 21. The participant is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.

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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

  • Sekino Clinical Pharmacology Clinic

    Toshima-ku, Tokyo, Japan

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