A phase 1, Open-Label, randomized, crossover study to evaluate the bioequivalence of soticlestat oral tablet formulations and the effect of food and tablet crushing on the pharmacokinetics of soticlestat in healthy adult participants
NCT ID NCT05284760
First seen Sep 10, 2026 ยท Last updated Sep 10, 2026
Summary
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce. Participants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase i, randomized, Double-Blind, Positive-Controlled, Parallel-Group pharmacokinetic clinical study of cetuximab injection versus erbitux in healthy male subjects
- A phase 1, Open-Label study to evaluate the effect of itraconazole and mefenamic acid on the Single-Dose pharmacokinetic profile of soticlestat in healthy participants
- A phase 1 Open-Label study to evaluate the Drug-Drug interaction of rifampin as a strong CYP3A inducer on soticlestat pharmacokinetics in healthy adult participants
- Comparative effects of three breathing techniques on heart rate variability, attention, reaction time, and anxiety in healthy adults: a randomized controlled trial
- An Open-Label phase 1 study to assess the safety, tolerability, and pharmacokinetics of a single dose of a new tablet formulation of TRTL-729 in healthy adults
- A phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years of age and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV)