Cardiodynamic evaluation of sorfequiline (TBAJ-876): results from a first-in-human study.

Sorfequiline (TBAJ-876) is a novel diarylquinoline under development for tuberculosis. In a first-in-human, multiple-ascending-dose study, electrocardiogram and pharmacokinetic data were analyzed to assess cardiac repolarization. Placebo-corrected change-from-baseline in QTcF (ΔΔQTcF) ranged from -11.4 to +2.4 ms without dose dependency. Concentration-QTc modeling showed a shallow, non-significant slope. The predicted mean effect on ΔΔQTcF at the maximum geometric mean Cmax of sorfequiline's M3 metabolite was -1.1 ms (90% CI -9.5 to 7.4).CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06058299.