Dataset Information

Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

ABSTRACT: BACKGROUND:Daptomycin is approved for the treatment of complicated skin and skin-structure infections and Staphylococcus aureus bacteremia. We sought to characterize daptomycin single-dose pharmacokinetics and tolerability in young infants. METHODS:Subjects < 120 days of age with suspected systemic infections were eligible for inclusion. Each subject was given a single 6 mg/kg intravenous dose of daptomycin. An average of 4 postdose concentrations per infant was obtained. RESULTS:Data from 20 infants are presented. Median gestational age at birth and postnatal age were 32 weeks (range: 23, 40) and 3 days (1, 85), respectively. The median area under the concentration curve at 24 hours, volume of distribution, total body clearance and half-life of daptomycin were 262.4 mg×h/L (166.7, 340.2), 0.21 L/kg (0.11, 0.34), 0.021 L/h/kg (0.016, 0.034) and 6.2 hours (3.7, 9.0), respectively. No adverse events related to daptomycin were observed, including changes in creatine phosphokinase concentrations. CONCLUSIONS:Daptomycin clearance in young infants was similar to that in children 2-6 years of age and higher than that observed in adolescents and adults.

SUBMITTER: Cohen-Wolkowiez M

PROVIDER: S-EPMC3421038 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

Cohen-Wolkowiez Michael M Watt Kevin M KM Hornik Christoph P CP Benjamin Daniel K DK Smith P Brian PB

The Pediatric infectious disease journal 20120901 9

<h4>Background</h4>Daptomycin is approved for the treatment of complicated skin and skin-structure infections and Staphylococcus aureus bacteremia. We sought to characterize daptomycin single-dose pharmacokinetics and tolerability in young infants.<h4>Methods</h4>Subjects < 120 days of age with suspected systemic infections were eligible for inclusion. Each subject was given a single 6 mg/kg intravenous dose of daptomycin. An average of 4 postdose concentrations per infant was obtained.<h4>Resul ...[more]

PMID: 22627869

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Project description:ObjectiveFabry disease is a rare X-linked disease caused by mutations to the GLA gene, resulting in a deficiency of the lysosomal enzyme alpha-galactosidase A. This study evaluated the pharmacokinetics, safety, and tolerability of ascending single doses of oral migalastat hydrochloride (HCl), an investigational drug, in healthy Japanese volunteers.MethodsIn this phase I, randomized, placebo-controlled, single-blind, ascending single-dose, cross-over study, migalastat HCl (50 mg, 150 mg, or 450 mg) or placebo was administered orally to 14 fasting male Japanese volunteers (aged 20-55 years) on 4 non-consecutive days. Main plasma and urine pharmacokinetic end-points included maximum observed plasma concentration (C max), time to C max (t max), area under the plasma concentration-time curve (AUC), apparent terminal-phase half-life (t 1/2), urinary recovery of unchanged drug, renal clearance, and percentage of drug excreted in urine. Safety end-points included adverse events, clinical signs and symptoms (e.g., hematology, chemistry, and urinalysis), vital signs (blood pressure and heart rate), and 12-lead electrocardiogram.Clinical trial registration numberClinicalTrials.gov registration identifier is NCT01853852.ResultsMedian t max of migalastat was 3.0-3.5 h. Migalastat HCl concentrations declined relatively rapidly, with a mean t 1/2 of 3.2-4.0 h. The amount of migalastat HCl recovered in the urine and the percentage of migalastat HCl excreted unchanged over 24 h were consistent (∼45-50%) across the dose range. The AUC and C max of migalastat HCl were dose proportional from 50-450 mg. Safety results were similar to those observed in non-Japanese populations.ConclusionsThis study demonstrated that ascending single doses of migalastat HCl (50 mg, 150 mg, 450 mg) are absorbed at a moderate rate and eliminated relatively rapidly, with a safety profile consistent with that observed in non-Japanese populations. These results confirm the dose-proportional pharmacokinetics of migalastat HCl from 50-450 mg. This study was limited by a small subject population and a short-term follow-up.

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Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

Publications

Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

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