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NCT06916897: EDG-5506-102
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
Phase 1 trial testing sevasemten in Healthy Subjects in 42 participants. Completed in 22 February 2025.
22 February 2025
Quick facts
| Lead sponsor | Edgewise Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 8 January 2025 |
| Primary completion | 22 February 2025 |
| Estimated completion | 22 February 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- sevasemten — full drug profile →
- Verapamil (VERAPAMIL) — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Edgewise Therapeutics, Inc. — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06916897
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Edgewise Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT07034768 — A Study to Evaluate EDG-7500 in People With Renal Impairment · Phase 1 · completed
- NCT06738836 — A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500 · Phase 1 · completed
- NCT06011317 — A Study of EDG-7500 in Healthy Adults · Phase 1 · completed
- NCT05730842 — Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers · Phase 1 · completed
- NCT05492734 — A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06916897 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Edgewise Therapeutics, Inc.
- Last refreshed: 8 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06916897.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing