Why the study?
Does single-dose ritonavir 100 mg cause QTc prolongation in healthy subjects?
Does single-dose ritonavir 100 mg cause QTc prolongation in healthy subjects?
A single 100 mg dose of ritonavir does not prolong the QTc interval in healthy subjects, suggesting it could replace ketoconazole as a CYP3A4 inhibitor in thorough QTc studies.
Answers are grounded in this paper and cite their sources.
Ritonavir 100 mg does not prolong QTc; supports its use as a CYP3A4 inhibitor alternative in thorough QT studies.
To assess the QTc prolongation by ritonavir (RTV) 100 mg and explore its potential use as CYP3A inhibitor in thorough QTc (TQT) studies. Randomized, crossover study of single-dose RTV 100 mg, placebo, and moxifloxacin (MFLX) 400 mg in 65 healthy subjects with serial triplicate electrocardiograms obtained for 12 h post-dose. Largest mean placebo-adjusted QTcF increase from baseline (90% confidence interval (CI)) for RTV 100 mg was noninferior to placebo (0.16 ms (-1.38, 1.69)). Study sensitivity was validated by detecting the largest mean placebo-adjusted QTcF increase from baseline (90% CI) for MFLX of 8.31 ms (6.44, 10.18). A single dose of RTV 100 mg does not cause QTc prolongation in healthy subjects. Based on the potent CYP3A4 inhibition, lack of QTc effect and better safety profile, RTV 100 mg could replace ketoconazole as the CYP3A4 inhibitor in TQT studies.
No takes yet. Share an insight, caveat, or question.
Sarapa et al. (2007) studied this question.
Synapse has enriched 10 related papers. Consider them for comparative context: