Safety, Pharmacokinetics, and Pharmacodynamics of BI 1595043, a Selective Vanin Inhibitor, in Phase 1 Clinical Trials Involving Healthy Volunteers.

ABSTRACT: BI 1595043 is an oral vanin-1 and vanin-2 inhibitor, which demonstrated promising effects on epithelial cell protection and reduction of inflammatory mediators in preclinical studies, as well as an acceptable safety profile in a previous single-rising-dose trial. Here, we report the results of a double-blind, randomized, placebo-controlled, multiple rising dose study, which investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1595043 in healthy male volunteers following oral administration of single and multiple rising doses over 18 days in total. Thirty subjects were treated (18-50 years of age; body mass index: 18.5-29.9 kg/m²); each dose group included 10 subjects, of which eight were administered BI 1595043 (15, 30, or 60 mg) and two were admin

SUBMITTER: Kukreja A 

PROVIDER: S-EPMC12435493 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature