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

NCT ID: NCT06916897

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-02-22

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A: single dose sevasemten

Single dose sevasemten administered on Day 1 under fasting conditions

Group Type: EXPERIMENTAL

sevasemten

Intervention Type: DRUG

single dose 10mg sevasemten administered orally

Treatment B: multiple doses of verapamil and single dose of sevasemten

Multiple doses of verapamil with a single dose of sevasemten under fasting conditions

Group Type: EXPERIMENTAL

sevasemten

Intervention Type: DRUG

single dose 10mg sevasemten administered orally

Verapamil

Intervention Type: DRUG

multiple doses 240mg verapamil

Treatment C: single dose sevasemten and high-fat meal

Single dose sevasemten under high-fat fed conditions

Group Type: EXPERIMENTAL

sevasemten

Intervention Type: DRUG

single dose 10mg sevasemten administered orally

Interventions

sevasemten

single dose 10mg sevasemten administered orally

Intervention Type: DRUG

Verapamil

multiple doses 240mg verapamil

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Edgewise Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxana D Dreghici, MD

Role: STUDY_CHAIR

Edgewise Therapeutics, Inc.

Locations

Celerion

Tempe, Arizona, United States

Celerion

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

EdgewiseTX

Identifier Type: -

Identifier Source: org_study_id