Clinical trial NCT06916897: A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Verapamil and Food on the Pharmacokinetics of Sevasemten in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Edgewise Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
2. 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.
3. Body mass index (BMI) ≥ 18.0 and \< 30.0 kg/m2 at the screening visit.
4. Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
5. Willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
2. History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
3. Female subjects of childbearing potential.
4. Alcohol consumption \> 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
5. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
6. 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.
7. Is lactose intolerant.
8. Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.

Primary outcomes:
measure: Pharmacokinetic
timeFrame: Up to 46 days of monitoring
measure: Pharmacokinetic
timeFrame: Up to 46 days of monitoring
measure: Pharmacokinetic
timeFrame: up to 42 days of monitoring
measure: Pharmacokinetic
timeFrame: up to 42 days of monitoring
measure: Pharmacokinetic
timeFrame: up to 42 days of monitoring
measure: Pharmacokinetic
timeFrame: up to 42 days of monitoring
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
measure: Safety and Tolerability
timeFrame: Up to 46 days of monitoring
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Edgewise Therapeutics, Inc.
name: Roxana D Dreghici, MD
role: STUDY_CHAIR
References: