Can a crushed pill or a meal change how soticlestat enters the blood?
NCT ID NCT05284760
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether three different tablet forms of the experimental drug soticlestat deliver the same amount of drug into the bloodstream. They also want to know whether taking the tablet with food or crushing it and mixing it with applesauce changes how the body absorbs it. The study enrolls healthy adult volunteers who take single 300 mg doses in different sequences and provide blood samples over time. Participants also have physical exams, heart rhythm checks, and safety monitoring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- soticlestat, an experimental drug also known as TAK-935
- What this could lead to
- If the tablet forms match and food does not change absorption, this could support simpler dosing options for future soticlestat trials.
- What could go wrong
- This is an early Phase 1 study in healthy volunteers, so it cannot show whether soticlestat works for any condition. Results may not apply to patients or to other doses.
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
-
96 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Jun 2022
- 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 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.
Key Inclusion Criteria: 1. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening. 2. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Investigator or designee. 4. Able to swallow multiple tablets. Key Exclusion Criteria: 1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. 2. Positive urine drug or alcohol results at screening or check-in. 3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). 4. Unable to refrain from or anticipates the use of: * Any drug, 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 the first dosing. * Any drugs known to be significant inducers of cytochrome P450 (CYP) 3A, CYP2C19, uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A9 or UGT2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug. 5. History of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer \[354 milliliter per 12 ounce {mL/12 oz}\], wine \[118 mL/4 oz\], or distilled spirits \[29.5 mL/1 oz\] per day). 6. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. 7. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. 8. Donation of blood or significant blood loss within 56 days prior to the first dosing. 9. Plasma donation within 7 days prior to the first dosing.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion
Tempe, Arizona, 85283, United States
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