{
  "abstract": "Sevasemten (EDG-5506) is an investigational, small molecule, in development for the treatment of Becker and Duchenne muscular dystrophy. In vitro data suggest sevasemten is a substrate for cytochrome P450 (CYP)3A4. Here, we investigate whether the pharmacokinetics (PK) of sevasemten are affected when co-administered with a moderate CYP3A4 inhibitor, verapamil. The impact of a high-fat meal on the PK of sevasemten was also investigated. This Phase 1, open-label, parallel study of healthy subjects dosed three unique cohorts (sevasemten alone, sevasemten co-administered with verapamil, and sevasemten under fed conditions). Administration of a single dose of sevasemten with daily dosing of verapamil had no significant effect on the maximum concentration (Cmax) or area under the plasma concentration-time curve (AUC) of sevasemten compared to a single dose of sevasemten under fasted conditions (Geometric mean ratios of 101.6% and 97.5%, respectively), indicating that the PK of sevasemten may not be influenced by verapamil, a moderate CYP3A4 inhibitor. Administration of a single dose of sevasemten under fed conditions increased the AUCs of sevasemten by 20% to 38%, while the Cmax remained comparable to that under fasted conditions. Together, these data support allowing patients who benefit from sevasemten to also use a moderate CYP3A inhibitor without dose modification and support administration of sevasemten without regard to food intake.",
  "abstract_shown": true,
  "affiliations": [
    "Edgewise Therapeutics, Inc., Boulder, Colorado, USA."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 3,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Molly Madden"
    },
    {
      "affs": [
        0
      ],
      "name": "Roxana Donisa Dreghici"
    },
    {
      "affs": [
        0
      ],
      "name": "Jeffrey A Silverman",
      "orcid": "0009-0001-3208-016X"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/88p8enatqkmaw.bib",
  "cited_by": 0,
  "doi": "10.1111/cts.70751",
  "fulltext_url": "https://europepmc.org/articles/PMC13729000",
  "id": "88p8enatqkmaw",
  "issns": [
    "1752-8054",
    "1752-8062"
  ],
  "landing_url": "https://europepmc.org/article/MED/42974700",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Article"
    ],
    [
      "openalex",
      "3004|Pharmacogenetics and Drug Metabolism"
    ]
  ],
  "openalex": "W7225160844",
  "pdf_url": "https://europepmc.org/articles/PMC13729000?pdf=render",
  "pmcid": "PMC13729000",
  "pmid": "42974700",
  "published": "2026-11-01",
  "publisher": "Wiley",
  "ris": "https://research.draconitic.com/paper/88p8enatqkmaw.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T15:20:47Z",
      "native_id": "MED:42974700",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42974700"
    },
    {
      "first_seen": "2026-11-07T12:21:50Z",
      "native_id": "PMC13729000",
      "source": "pmc",
      "url": "https://doi.org/10.1111/cts.70751"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3004|Pharmacogenetics and Drug Metabolism",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Phase 1 Evaluation of the Pharmacokinetics of Sevasemten (EDG-5506) for Potential Food Effect and Drug-Drug Interaction With a CYP3A4 Moderate Inhibitor.",
  "title_text": "Phase 1 Evaluation of the Pharmacokinetics of Sevasemten (EDG-5506) for Potential Food Effect and Drug-Drug Interaction With a CYP3A4 Moderate Inhibitor.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T12:21:50Z",
  "url": "https://research.draconitic.com/paper/88p8enatqkmaw",
  "venue": "Clinical and translational science",
  "versions": []
}