The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of mitiperstat
Mitiperstat apparent clearance was approximately twofold lower in individuals with severe renal impairment than in those with normal renal function. Lower clearance was driven by reduced renal clearance; non-renal clearance was similar. Mitiperstat was generally well tolerated by participants with severe renal impairment and normal renal function. These findings, together with efficacy and safety/tolerability data from phase 2b, will guide the dosing regimen for phase 3.
Authors
- Julie Holden
- Mikael Sunnåker (ORCID: https://orcid.org/0009-0003-5881-4998)
- Karin Nelander (ORCID: https://orcid.org/0000-0002-2649-1130)
- Patricia Ely Pizzato
- Hans Ericsson (ORCID: https://orcid.org/0000-0001-6038-4331)
- Maria Heijer
- Anna Collén (ORCID: https://orcid.org/0000-0002-3220-7247)
- Malin Aurell
- Chandrali Bhattacharya (ORCID: https://orcid.org/0000-0002-3224-1306)
- Monika Trebski
- Hodan Ali
- Diyan K. Genov
Institutions
- AstraZeneca (Sweden) (SE)
- AstraZeneca (United States) (US)
- National Patient Safety Foundation (US)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2024-08-12
- DOI
- https://doi.org/10.1111/bcp.16205
- Citations
- 2
- Primary Topic
- Pharmacological Effects and Toxicity Studies
- Type
- article
- Field-Weighted Citation Impact
- 2.22
Funders
- AstraZeneca