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

April 1, 2025 updated by: Edgewise Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil
Up to 46 days of monitoring
Pharmacokinetic
Time Frame: up to 42 days of monitoring
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
Time Frame: up to 42 days of monitoring
The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions
up to 42 days of monitoring
Pharmacokinetic
Time Frame: up to 42 days of monitoring
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
Time Frame: 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
up to 42 days of monitoring

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: Up to 46 days of monitoring
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
Time Frame: 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
Up to 46 days of monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edgewise Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Roxana D Dreghici, MD, Edgewise Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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