Can common medicines change how the body handles an experimental drug?
NCT ID NCT05064449
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether two medicines, itraconazole and mefenamic acid, change the way the body processes an experimental drug called soticlestat. The study enrolls healthy adult volunteers who take soticlestat alone and then with one of the other drugs. By measuring levels of soticlestat in the blood over time, the team aims to understand potential drug interactions that could affect dosing or safety in future patients.
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, tested alone and with itraconazole or mefenamic acid
- What this could lead to
- If the study shows these drugs change how the body handles soticlestat, doctors may learn how to adjust doses or avoid risky combinations when soticlestat is used in future patients.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, so the results may not apply to people with the condition soticlestat is meant to treat. The drug interactions seen in healthy people may differ from those in patients, and the study does not test whether soticlestat works for any disease.
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
-
28 people
The number who actually took part.
- Started
-
Oct 2021
- Finished
-
Nov 2021
- 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
-
19 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.
Inclusion Criteria: 1. Has body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per meter square (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 or electrocardiograms (ECGs), as deemed by the Investigator or designee. * Supine blood pressure is \>=90/40 millimeter of mercury (mmHg) and \<=140/90 mmHg at screening; * Supine pulse rate is \>=45 beats per minute (bpm) and \<=100 bpm at screening; * QT interval corrected for pulse rate using Fridericia's formula (QTcF) is \<=450 millisecond (msec) (males) or \<=470 msec (females) and ECG findings considered normal or not clinically significant by the Investigator or designee at screening; * Estimated creatinine clearance \>=80 milliliter per minute (mL/min) at screening; * Liver function tests including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<=1.5\*the upper limit of normal (ULN) at screening and check-in. 4. Able to swallow multiple tablets. Exclusion Criteria: 1. Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participants by their participation in the study. 2. Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. 3. Has history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds. 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 first dosing. 5. Has history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer 354 milliliter (mL)/12 Ounce \[oz\], 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 120 mg 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. 10. Has participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Celerion
Lincoln, Nebraska, 68502, United States
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