Healthy SubjectsPhase 1EDG-5506-102NCT06916897
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
A Phase 1 study testing sevasemten and Verapamil in people with Healthy Subjects, run by Edgewise Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- sevasemten and Verapamil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2025to 22 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
- 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.
- Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
- Willing and able to comply with the protocol.
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
- Female subjects of childbearing potential.
- Alcohol consumption > 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
- 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.
- Is lactose intolerant.
- Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion
Tempe, Arizona, 85283
About this study
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
The purposes of this Phase 1 study of sevasemten are to:
- Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.
- Conditions
- Healthy Subjects
- Being tested
- sevasemten, Verapamil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevasemtenDrug
single dose 10mg sevasemten administered orally
VerapamilDrug
multiple doses 240mg verapamil
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: single dose sevasemten | Experimental | Single dose sevasemten administered on Day 1 under fasting conditions Receives: Drug: sevasemten |
| Treatment B: multiple doses of verapamil and single dose of sevasemten | Experimental | Multiple doses of verapamil with a single dose of sevasemten under fasting conditions Receives: Drug: sevasemten; Drug: Verapamil |
| Treatment C: single dose sevasemten and high-fat meal | Experimental | Single dose sevasemten under high-fat fed conditions Receives: Drug: sevasemten |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 46 days of monitoring
Pharmacokinetic
The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil
Measured: 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
Measured: up to 42 days of monitoring
Pharmacokinetic
The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions
Measured: 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
Measured: 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
Measured: up to 42 days of monitoring
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 46 days of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start8 Jan 2025
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxana D Dreghici, MD, Study chair, Edgewise Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916897
- Sponsor's protocol ID
- EdgewiseTX
- Acronym
- EDG-5506-102
- Status last verified
- Apr 2025
- First submitted
- 13 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916897
- Acronym / sponsor ID
- EDG-5506-102 / EdgewiseTX
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this Phase 1 study of sevasemten are to:
- Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: single dose sevasemten | Experimental | Drug: sevasemtenSingle dose sevasemten administered on Day 1 under fasting conditions |
| Treatment B: multiple doses of verapamil and single dose of sevasemten | Experimental | Drug: sevasemten, Drug: VerapamilMultiple doses of verapamil with a single dose of sevasemten under fasting conditions |
| Treatment C: single dose sevasemten and high-fat meal | Experimental | Drug: sevasemtenSingle dose sevasemten under high-fat fed conditions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
- 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.
- Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
- Willing and able to comply with the protocol.
Key exclusion criteria (8 listed)
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
- Female subjects of childbearing potential.
- Alcohol consumption > 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevasemtensingle dose 10mg sevasemten administered orally | Drug | Treatment A: single dose sevasemten, Treatment B: multiple doses of verapamil and single dose of sevasemten, Treatment C: single dose sevasemten and high-fat meal |
| Verapamilmultiple doses 240mg verapamil | Drug | Treatment B: multiple doses of verapamil and single dose of sevasemten |
Primary outcome
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
Pharmacokinetic
Time frame: Up to 46 days of monitoring
The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil
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
Pharmacokinetic
Time frame: up to 42 days of monitoring
The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions
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
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
9 secondary outcomes
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Safety and Tolerability
Time frame: Up to 46 days of monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxana D Dreghici, MD study chair
Edgewise Therapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sevasemten and Verapamil in people with Healthy Subjects, run by Edgewise Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (time frame: Up to 46 days of monitoring). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.