Status:
COMPLETED
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
Lead Sponsor:
Edgewise Therapeutics, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06916897
Start Date
January 8 2025
End Date
February 22 2025
Last Update
April 8 2025
Active Locations (2)
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1
Celerion
Tempe, Arizona, United States, 85283
2
Celerion
Lincoln, Nebraska, United States, 68502