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

NCT06916897 | Completed Phase 1 FDA Drug

• 1 other identifier: EdgewiseTX
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this Phase 1 study of sevasemten are to:

1. 1.Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
2. 2.Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
3. 3.Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Safety and Tolerability

  Up to 46 days of monitoring

• Safety and Tolerability

  Up to 46 days of monitoring

• Safety and Tolerability

  Up to 46 days of monitoring

• Safety and Tolerability

  Up to 46 days of monitoring

• Safety and Tolerability

  Up to 46 days of monitoring

Study Arms (3)

Treatment A: single dose sevasemten

EXPERIMENTAL

Single dose sevasemten administered on Day 1 under fasting conditions

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

Drug: sevasemten; Drug: Verapamil

Treatment C: single dose sevasemten and high-fat meal

EXPERIMENTAL

Single dose sevasemten under high-fat fed conditions

Drug: sevasemten

Interventions

sevasemten DRUG

single dose 10mg sevasemten administered orally

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

Verapamil DRUG

multiple doses 240mg verapamil

Treatment B: multiple doses of verapamil and single dose of sevasemten

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (2)

Celerion

Tempe, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Verapamil

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Roxana D Dreghici, MD

  Edgewise Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: April 8, 2025
• Study Start: January 8, 2025
• Primary Completion: February 22, 2025
• Study Completion: February 22, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (2)