Phase 1
Completed N=96
A Study of Soticlestat Tablets in Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT05284760 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for Soticlestat — 1762; 1428; 1708; 1509 nanogram per milllilitre (ng/ml)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Soticlestat |
1762; 1428; 1708; 1509; 565.6; 1350 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat |
1649; 1433; 1606; 1503; 1317; 1435 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat |
1659; 1459; 1639; 1525; 1354; 1395 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
6; 12; 7; 0; 2; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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.
- Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Investigator or designee.
- Able to swallow multiple tablets.
Key Exclusion Criteria
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at screening or check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- 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.
- 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).
- 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.
- 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.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Data sourced from ClinicalTrials.gov (NCT05284760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.