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Completed

NCT Number: NCT06916897

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

sevasemten

Drug

single dose 10mg sevasemten administered orally

Verapamil

Drug

multiple doses 240mg verapamil

Primary outcomes

  1. 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

  2. Pharmacokinetic

    Time frame: Up to 46 days of monitoring

    The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil

  3. 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

  4. Pharmacokinetic

    Time frame: up to 42 days of monitoring

    The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: EDG-5506-102

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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