Epilepsy drug candidate put to the test in healthy volunteers
NCT ID NCT02539134
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called TAK-935 in healthy adults to see how safe and tolerable it is. The trial gives participants multiple increasing doses or a placebo and tracks side effects, vital signs, heart rhythms, and blood levels of the drug. The goal is to understand how the body processes TAK-935 and whether it is safe enough to study further in people with epilepsy.
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 oral drug
- What this could lead to
- If TAK-935 proves safe and well tolerated, researchers could move it into studies with people who have epilepsy.
- What could go wrong
- This is a small, early-stage trial in healthy volunteers, so it cannot show whether the drug works for epilepsy. Many drugs fail at this stage, and side effects may emerge only in larger studies.
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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40 people
The number who actually took part.
- Start date
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Sep 2015
- Finished
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Apr 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
-
18 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: All Cohorts 1. 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 aged 18 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 and Day -1. 5. Male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose. 6. Female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study, and for 30 days after the last dose. 7. Can complete the CogState Battery at Screening. Additional Inclusion Criteria for Participants undergoing cerebrospinal fluid (CSF) Sampling (Part 2 only): 8. Agrees to spinal tap procedures for CSF collection. Exclusion Criteria: All Cohorts 1. Has received any investigational compound within 30 days prior to randomization. 2. Has received TAK-935 in a previous clinical study or as a therapeutic agent. 3. Has a significant history of uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease or psychiatric disorder or endocrine disease or other abnormality or any significant results from physical examinations, or clinical laboratory results which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted. 4. Has a known hypersensitivity to any component of the formulation of TAK-935. 5. 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. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine. 6. Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table. Additional Exclusion Criteria for Participants undergoing CSF sampling (Part 2) 7. Has CSF collection performed within 30 days prior to check-in (Day -3). 8. Has a known hypersensitivity to the anesthetic or its derivatives used during CSF collection, or any medication used to prepare the area of lumbar puncture. 9. Has significant vertebral deformities (scoliosis or kyphosis) which, in the opinion of the investigator, may interfere with lumbar puncture procedure. 10. Has a history of clinically significant back pain and/or injury. 11. Has local infection at the puncture site.
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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
-
Study site
Austin, Texas, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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