Cempra announced that solithromycin demonstrated safety and tolerability in patients with mild to severe chronic liver disease. The pharmacokinetic analyses also showed that no dosage adjustments to compensate for decreased liver function were necessary in this patient population. In this hepatic impairment study, 24 patients with chronic liver disease, eight with mild disease, eight with moderate disease and eight with severe disease, were given a five-day course of solithromycin dosed as 800 mg on day 1 followed by 400 mg once-daily on days two through five. The pharmacokinetics of solithromycin in these three patient groups were evaluated and compared to a matched healthy control cohort given the same regimen. Solithromycin is currently in a global Phase 3 clinical trial in patients with community-acquired bacterial pneumonia, to evaluate both the safety and efficacy in this patient population.
- Disease & Medical Conditions
- chronic liver disease