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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: sevasemten; Drug: Verapamil

• Registration Number: NCT06916897
• Lead Sponsor: Edgewise Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-08
• Study First Submitted: 2025-02-13
• Primary Completion: 2025-02-22
• Study Completion: 2025-02-22
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: single dose sevasemten	sevasemten	Single dose sevasemten administered on Day 1 under fasting conditions
Treatment B: multiple doses of verapamil and single dose of sevasemten	sevasemten	Multiple doses of verapamil with a single dose of sevasemten under fasting conditions
Treatment B: multiple doses of verapamil and single dose of sevasemten	Verapamil	Multiple doses of verapamil with a single dose of sevasemten under fasting conditions
Treatment C: single dose sevasemten and high-fat meal	sevasemten	Single dose sevasemten under high-fat fed conditions

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic	up to 42 days of monitoring	The lag time, time delayed between drug administration and the onset of absorption (Tlag), for sevasemten and metabolites under fasting and fed conditions

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	Up to 46 days of monitoring	Incidence of abnormal 12-lead ECG results in those with a single dose of sevasemten administered with and without verapamil and with or without food

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States