Can a single dose of TAK-935 hit its brain target? PET scans aim to find out
NCT ID NCT02497235
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a single oral dose of the experimental drug TAK-935 reaches and blocks a specific enzyme in the brain called cholesterol 24S-hydroxylase (CH24H). The study enrolls healthy adults aged 19 to 55. Using PET imaging with a tracer called [18F]MNI-792, the team measures how much of the enzyme is occupied by the drug and how that relates to drug levels in the blood.
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 an oral solution
- What this could lead to
- If the drug reaches its target in the brain as intended, this could guide future research into treatments for epilepsy and other brain conditions.
- What could go wrong
- This is a very small, early-stage study in healthy volunteers, so it cannot show whether the drug works for any disease. The results may not apply to people with epilepsy, and the drug could cause side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Start date
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Jul 2015
- Finished
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Jan 2016
- Lead sponsor
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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
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19 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. In the opinion of the investigator, is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations. 3. Is a healthy male or female and aged 19 to 55 years, inclusive, at the time of informed consent and first study medication dose. 4. 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. 5. A female of non-bearing potential (example post-menopausal by history; or history of hysterectomy, bilateral salpingectomy, or oophorectomy). Exclusion Criteria: 1. Have a known history or evidence of a clinically significant disorder (including neurologic and psychiatric), or disease that in the opinion of the study investigator would pose a risk to the participant safety or interfere with the study evaluation, procedures or completion. 2. Contraindication to magnetic resonance imaging (MRI) based on the standard MRI radiography screening questionnaire. 3. Had exposure to any radiation greater than (\>) 15 millisievert (mSv)/year (example, occupational or radiation therapy) within the previous year prior to Baseline imaging. 4. Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds, or to \[18F\]MNI-792 or to any of its components. 5. Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the PET imaging. 6. Use of any over-the-counter, herbal, or prescription medications or supplements within 30 days prior to baseline imaging.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Study site
New Haven, Connecticut, United States