Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation
PBPK modeling of trofinetide in a virtual population with moderate renal impairment predicted a 50% dose reduction compared to individuals with normal renal function. Comparison of observed pharmacokinetic results from a phase 1 study in subjects with moderate renal impairment and matched healthy participants to the model-predicted exposures validated this dose reduction. No new safety concerns for trofinetide emerged.
Authors
- Viera Lukáčová
- Thomas Marbury (ORCID: https://orcid.org/0000-0002-6416-3314)
- Inger M. Darling
- Kathie M. Bishop
- Mona Darwish
- James M. Youakim (ORCID: https://orcid.org/0000-0001-5551-8956)
- Di An (ORCID: https://orcid.org/0000-0001-6171-7791)
- René Núñez
Institutions
- Acadia Pharmaceuticals (United States) (US)
- Orlando Clinical Research Center (US)
- Simulations Plus (United States) (US)
Publication Details
- Journal
- European Journal of Drug Metabolism and Pharmacokinetics
- Published
- 2024-11-08
- DOI
- https://doi.org/10.1007/s13318-024-00924-1
- Citations
- 2
- Primary Topic
- Bipolar Disorder and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.77
Funders
- ACADIA Pharmaceuticals