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Tablet or liquid? scientists map how the body takes up an experimental drug

NCT ID NCT02906813

Knowledge-focused Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing how the body absorbs TAK-935, an experimental drug, when given as a 300 mg tablet compared with a 300 mg oral solution. They also want to know whether taking the tablet with food changes how much of the drug reaches the bloodstream. The study enrolls a small group of healthy adults who receive single doses and provide blood samples. The goal is to understand the drug's behavior in the body, not to treat any condition.

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 given as a tablet or oral solution
What this could lead to
If the tablet form delivers the drug reliably, it could support later trials that test TAK-935 as a treatment for neurological or psychiatric conditions.
What could go wrong
This is a tiny Phase 1 study in healthy volunteers, so it cannot show whether the drug works for any disease. It only measures blood levels and short-term safety.

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

9 people

The number who actually took part.

Started

Sep 2016

Finished

Nov 2016

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\. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -2. Exclusion Criteria: 1. Has received TAK-935 in a previous clinical study or as a therapeutic agent. 2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria. 3. Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine. 4. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1. 5. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection. 6. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1). 7. Has poor peripheral venous access. 8. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.

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As listed by the trial registrant

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

Healthy volunteers

Contacts and locations

Locations

  • Study site

    Glendale, California, United States

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