Assessment of QT Interval Prolongation Using Concentration-QT Modeling for Iptacopan, an Oral Complement Factor B Inhibitor, in Healthy Individuals.

ABSTRACT: To assess cardiac and safety parameters of iptacopan (an oral, selective, reversible, small-molecule factor B inhibitor), we conducted a phase I, single ascending dose (SAD), exposure-response study (A2107) instead of a traditional thorough QT study. Healthy participants were randomized 3:1 to receive a single, supratherapeutic, oral dose of iptacopan 400, 800, or 1200 mg, or placebo. A2107's primary objectives were to assess iptacopan's effect on Fridericia-corrected QT interval (QTcF) in a pooled analysis with the SAD phase of the first-in-human X2101 study, and the safety and tolerability of supratherapeutic iptacopan doses in participants. Secondary objectives included pharmacokinetics, changes in selected electrocardiogram (ECG) parameters, and categorical changes to the QTcF, PR, and

SUBMITTER: Kaetterer N 

PROVIDER: S-EPMC12519509 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature