BV100 (rifabutin for infusion) showed dose-proportional pharmacokinetics and safety in healthy volunteers.

This Phase 1 randomized controlled trial assessed the pharmacokinetics, safety, and tolerability of BV100, a formulation of rifabutin for infusion, in a population of healthy volunteers. The sample size was not reported, and the specific setting was not reported in the available data. The intervention involved single-ascending and multiple-ascending doses of BV100. No comparator was explicitly reported for the primary analysis in the provided text.

Regarding the main results, the study demonstrated a dose-proportional pharmacokinetic profile. The half-life of the drug ranged from 7.9 to 56.1 hours, while clearance values ranged from 1.0 to 1.75. When comparing dosing intervals, exposure was 1.5-fold to 2-fold greater with a q12h interval versus a q24h interval. Metabolite activity was observed to be less than 5% of rifabutin activity. Exact absolute numbers and p-values were not reported for these specific outcomes.

Safety and tolerability data indicated that the treatment was generally safe and well tolerated. Adverse events included infusion site events and systemic treatment-emergent adverse events. Serious adverse events were not reported, and discontinuations were not reported. The frequency of adverse events was noted to be higher at higher doses, particularly with the q24h dosing interval and a 60-minute infusion time.

Key limitations include the lack of reported sample size, setting, and specific statistical measures such as confidence intervals or p-values. The study population consisted of healthy volunteers, which limits the direct applicability to patients with carbapenem-resistant infections. The practice relevance notes that BV100 doses of 200-300 mg q12h are currently being evaluated in a Phase 2 study for treating carbapenem-resistant infections. Funding sources and conflicts of interest were not reported.