QTMeds

ELUCIREM 0

Clinical Description (Database Summary)

Gadopiclenol is a next-generation macrocyclic gadolinium-based contrast agent for magnetic resonance imaging that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In an ICH E14 thorough QT crossover study in 48 healthy volunteers with moxifloxacin positive control, clinical (0.1 mmol/kg) and supraclinical (0.3 mmol/kg) doses showed maximum placebo-corrected QTcF changes of 2.39 ms (upper 90% CI 4.43 ms) and 4.81 ms (upper 90% CI 6.78 ms), respectively, remaining strictly below the 10 ms regulatory threshold. Concentration-response analysis confirmed an absence of proarrhythmic potential despite mild hyperosmolarity.

Scientific Sources / References

https://doi.org/10.1111/bcp.14309