Could a new drug quietly change your heartbeat? a trial investigates
NCT ID NCT05309902
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This phase 1 trial is testing whether soticlestat, an experimental drug, has any effect on heart rate or rhythm. Healthy adult volunteers will receive multiple doses of soticlestat, a placebo, or an active control, and their heart activity will be monitored continuously via ECG. The study aims to see if soticlestat prolongs the QTc interval, a measure of heart electrical activity, which could indicate a risk for abnormal heart rhythms. Participants will also have blood samples taken and a follow-up call 14 days after the last dose to check for any health issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Soticlestat (also known as TAK-935), given as tablets, compared against placebo and an active control (moxifloxacin).
- What this could lead to
- If soticlestat shows no significant effect on heart rhythm, it could support its continued development as a treatment for neurological conditions.
- What could go wrong
- This is an early-phase safety study in a small number of healthy volunteers, so results may not predict effects in patients or guarantee the drug's overall safety.
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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.
- Expected to start
-
Oct 2022
An estimate. Start dates often move.
- Expected to finish
-
Dec 2022
An estimate. End dates often move.
- 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
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Anyone
- Healthy volunteers
-
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. Male participants agree to comply with any applicable contraceptive requirements of the protocol. 2. Body mass index (BMI) greater than or equal to (\>=)18.0 and \<=32.0 kilogram per square meter (kg/m\^2) at screening. 3. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing, based on participant self-reporting. 4. No clinically significant history or presence of ECG findings as judged by the Investigator or designee, including each criterion as listed below: * Normal sinus rhythm (HR between 45 bpm and 100 bpm inclusive) at screening and check-in; * QTcF is \<=450 ms (males) or \<=470 ms (females) at screening and check-in; * QRS interval \<=110 ms; if \>110 ms, result will be confirmed by a manual over read at screening and check-in; * PR interval \<=220 ms at screening and check-in. Exclusion Criteria: 1. Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. History or presence of any of the following, deemed clinically significant by the Investigator or designee: * epilepsy, seizure, or convulsion, tremor or related symptoms; * risk factors for Torsade de Pointes (TdP) (example, heart failure, unexplained syncope, cardiomyopathy, or family history of Long QT Syndrome); * family history of sudden death; * sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities; * ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder; * T wave flattening or other abnormalities which in the opinion of the investigator or designee may interfere with the analysis of QT intervals; * clinically significant hyper- or hypokalemia. 3. Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the clinical judgement of the Investigator has a risk of suicide or has made a suicide attempt in the previous 12 months prior to the first dosing. 4. Positive urine drug or alcohol results at screening or at check-in. 5. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or antibody test for hepatitis C virus (HCV). 6. Unable to refrain from or anticipates the use of: * Any vaccines, drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first dosing. * Any drugs known to be significant inducers of cytochrome P450 (CYP)3A, CYP2C19, uridine 5' diphospho-glucuronosyltransferase (UGT)1A9 or (UGT)2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of Pharmacokinetics (PK)/pharmacodynamics interaction with study drug. 7. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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