Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects

The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects. Ten CF subjects received single 180-mg doses of two formulations of MP-376, followed by a multiple-dose phase of 240 mg once daily for 7 days. Ser...

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Veröffentlicht in:Antimicrobial agents and chemotherapy Jg. 55; H. 6; S. 2636
Hauptverfasser: Geller, David E, Flume, Patrick A, Griffith, David C, Morgan, Elizabeth, White, Dan, Loutit, Jeffery S, Dudley, Michael N
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.06.2011
Schlagworte:
Administration, Inhalation
Adolescent
Adult
Anti-Bacterial Agents - pharmacokinetics
Area Under Curve
Cross-Over Studies
Cystic Fibrosis - drug therapy
Female
Humans
Levofloxacin
Male
Middle Aged
Ofloxacin - adverse effects
Ofloxacin - pharmacokinetics
Single-Blind Method
Solutions
ISSN:1098-6596, 1098-6596
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Zusammenfassung:The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects. Ten CF subjects received single 180-mg doses of two formulations of MP-376, followed by a multiple-dose phase of 240 mg once daily for 7 days. Serum and expectorated-sputum samples were assayed for levofloxacin content. Safety was evaluated following the single- and multiple-dose study phases. Nebulized MP-376 produced high concentrations of levofloxacin in sputum. The mean maximum plasma concentration (C(max)) ranged between 2,563 and 2,932 mg/liter for 180-mg doses of the 50- and 100-mg/ml formulations, respectively. After 7 days of dosing, the mean C(max) for the 240-mg dose was 4,691 mg/liter. The mean serum levofloxacin C(max) ranged between 0.95 and 1.28 for the 180-mg doses and was 1.71 for the 240-mg dose. MP-376 was well tolerated. Nebulized MP-376 produces high sputum and low serum levofloxacin concentrations. The pharmacokinetics, safety, and tolerability were similar for the two formulations. MP-376 240 mg (100 mg/ml) is being advanced into late-stage clinical development.
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ISSN:1098-6596
1098-6596
DOI:10.1128/AAC.01744-10