Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment.

ABSTRACT:

Objective

The aim of this study was to assess the effect of moderate or severe renal impairment on the pharmacokinetic (PK) properties of milvexian.

Methods

This open-label, parallel-group study assessed the PK, safety, and tolerability of a single oral 60 mg dose of milvexian in participants with normal renal function (n = 8; estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) and participants with moderate (n = 8; eGFR ≥ 30 to ≤ 59 mL/min/1.73 m²) or severe (n = 8; eGFR < 30 mL/min/1.73 m²) renal impairment. Regression analysis was performed using linear regression of log-transformed PK parameters versus eGFR.

Results

Milvexian was well tolerated, with no deaths, serious adverse events, or serious bleeding reported. The

SUBMITTER: Perera V 

PROVIDER: S-EPMC9553801 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature