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

## TL;DR

This study evaluated the heart effects of a new tuberculosis drug in humans and found no significant changes in cardiac repolarization.

## Contribution

The first-in-human assessment of sorfequiline's cardiodynamic effects provides critical safety data for its development.

## Key findings

- 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 M3 metabolite's Cmax was −1.1 ms.

## Abstract

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).

This study is registered with ClinicalTrials.gov as NCT06058299.