A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.

Key facts

Study ID

NCT05064449

Run by

Takeda

People needed

28

Starts

2021-10-14

Expected to finish

2021-11-30

Last updated by the study team

2023-10-03

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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 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.
• Able to swallow multiple tablets.

You may not qualify if…

• 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.
• Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• Has history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• 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.
• 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).
• 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.
• 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.
• 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.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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