NCT06916897

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Edgewise Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	sevasemten	single dose 10mg sevasemten administered orally
DRUG	Verapamil	multiple doses 240mg verapamil

Timeline

• Start date: 2025-01-08
• Primary completion: 2025-02-22
• Completion: 2025-02-22
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study