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

NCT06916897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-08

No results posted yet for this study

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

DRUG

sevasemten

single dose 10mg sevasemten administered orally

DRUG

Verapamil

multiple doses 240mg verapamil

Sponsors & Collaborators

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Roxana D Dreghici, MD · Edgewise Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2025-02-22
Completion
2025-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916897 on ClinicalTrials.gov