A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

The purposes of this Phase 1 study of sevasemten are to: 1. Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults 2. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects. 3. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.

Key facts

Study ID

NCT06916897

Run by

Edgewise Therapeutics, Inc.

People needed

42

Starts

2025-01-08

Expected to finish

2025-02-22

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
• Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
• Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2 at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
• Willing and able to comply with the protocol.

You may not qualify if…

• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
• Female subjects of childbearing potential.
• Alcohol consumption > 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
• Any drugs known to be moderate or strong inducers of CYP3A4 enzymes/or P glycoprotein, including St. John's Wort, beginning 28 days prior to the first dosing.
• Is lactose intolerant.
• Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.

Where it is running

• Celerion — Tempe, Arizona, United States
• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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