A phase 1, multicenter, open‐label study to evaluate the pharmacokinetics, safety, and tolerability of a single dose of rimegepant in children (aged ≥6 to <12 years) with a history of migraine
A single weight-adjusted dose of rimegepant ODT demonstrated a favorable safety profile in children aged ≥6 to <12 years with a history of migraine. Exposures in children >50 kg receiving 75 mg rimegepant were similar to observed exposures in adults receiving 75 mg. However, exposures in children >30 kg to ≤50 kg receiving 50 mg rimegepant and in children ≥15 kg to ≤30 kg receiving 25 mg rimegepant were lower than exposures in adults receiving 75 mg. These findings will be the basis for further refinement of pediatric dose in future studies.
Authors
- Richard Bertz (ORCID: https://orcid.org/0009-0006-4593-1310)
- Chay Ngee Lim (ORCID: https://orcid.org/0000-0002-7307-9851)
- Craig Comisar
- Ogert Fisniku
- Beth Emerson (ORCID: https://orcid.org/0000-0003-3646-0466)
- Robert Croop (ORCID: https://orcid.org/0009-0004-0151-1192)
- Kyle Matschke (ORCID: https://orcid.org/0009-0003-2043-851X)
- Gary Mo (ORCID: https://orcid.org/0000-0001-7805-5077)
- Jing Liu (ORCID: https://orcid.org/0000-0002-6730-9198)
- Rajinder Bhardwaj (ORCID: https://orcid.org/0009-0005-2720-2192)
Institutions
- BHP (Australia) (AU)
- Pfizer (United States) (US)
- Biohaven Pharmaceuticals (United States) (US)
- Horizon Therapeutics (United States) (US)
- Certara (United States) (US)
Publication Details
- Journal
- Headache The Journal of Head and Face Pain
- Published
- 2025-10-24
- DOI
- https://doi.org/10.1111/head.15074
- Citations
- 1
- Primary Topic
- Migraine and Headache Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.47
Funders
- Pfizer