A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers (EDG-5506-102)

A Phase 1, Open-Label Study to Evaluate the Effect of Verapamil and Food on the Pharmacokinetics of Sevasemten in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: sevasemten; Drug: Verapamil

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: single dose sevasemten; Single dose sevasemten administered on Day 1 under fasting conditions	Drug: sevasemten; single dose 10mg sevasemten administered orally
Experimental: Treatment B: multiple doses of verapamil and single dose of sevasemten; Multiple doses of verapamil with a single dose of sevasemten under fasting conditions	Drug: sevasemten; single dose 10mg sevasemten administered orally; Drug: Verapamil; multiple doses 240mg verapamil
Experimental: Treatment C: single dose sevasemten and high-fat meal; Single dose sevasemten under high-fat fed conditions	Drug: sevasemten; single dose 10mg sevasemten administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic	The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites administered with and without verapamil	Up to 46 days of monitoring
Pharmacokinetic	The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil	Up to 46 days of monitoring
Pharmacokinetic	The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites under fasting and fed conditions	up to 42 days of monitoring
Pharmacokinetic	The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions	up to 42 days of monitoring
Pharmacokinetic	The time to reach the maximum observed concentration (Tmax) for sevasemten and metabolites under fasting and fed conditions	up to 42 days of monitoring
Pharmacokinetic	The lag time, time delayed between drug administration and the onset of absorption (Tlag), for sevasemten and metabolites under fasting and fed conditions	up to 42 days of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence of treatment emergent adverse events in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal chemistry test results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal hematology test results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal urinalysis test results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal heart rate results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal blood pressure results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal body temperature results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	Incidence of abnormal respiratory rate results in those with a single dose of sevasemten administered with and without verapamil and with or without food	Up to 46 days of monitoring
Safety and Tolerability	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	Up to 46 days of monitoring

Collaborators and Investigators

• Sponsor: Edgewise Therapeutics, Inc.
• Investigators: Study Chair: Roxana D Dreghici, MD, Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): February 22, 2025
• Study Completion (Actual): February 22, 2025

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Calcium Channel Blockers; Vasodilator Agents; Verapamil
• Other Study ID Numbers: EdgewiseTX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No