Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study.

ABSTRACT:

Aim

To evaluate BAY 2433334, an oral activated factor XI (FXIa) inhibitor, in volunteers.

Methods

Phase 1 study of healthy men at a German centre. Part A: randomized, single-blind, multiple dose-escalation study of BAY 2433334 (25/50/100 mg once daily [OD]) vs. placebo. Part B: similar design to Part A; evaluated BAY 2433334 25 mg twice daily. Part C: nonrandomized, open-label study; evaluated potential interactions between BAY 2433334 (25/75 mg OD) and midazolam (7.5 mg), a CYP3A4 index substrate. Primary variables: treatment-emergent adverse events (TEAEs; Parts A and B); area under the plasma concentration-time curve (AUC) and maximum plasma concentration of midazolam and α-hydroxymidazolam (Part C).

Study period

18 days plus follow-up visit.

Results

Parts A

SUBMITTER: Kubitza D 

PROVIDER: S-EPMC9311154 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature