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Pharmacology

Human Pharmacokinetics and Safety Profile of Finafloxacin, a New Fluoroquinolone Antibiotic, in Healthy Volunteers

Heena Patel, Arne Andresen, Andreas Vente, Hans-Dietrich Heilmann, Will Stubbings, Michael Seiberling, Luis Lopez-Lazaro, Rolf Pokorny, Harald Labischinski
Heena Patel
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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Arne Andresen
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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Andreas Vente
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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Hans-Dietrich Heilmann
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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  • For correspondence: heilmann@merlionpharma.de
Will Stubbings
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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Michael Seiberling
2Covance Clinical Research Unit AG, Lettenweg 118, Allschwil (Basel), Switzerland
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Luis Lopez-Lazaro
2Covance Clinical Research Unit AG, Lettenweg 118, Allschwil (Basel), Switzerland
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Rolf Pokorny
2Covance Clinical Research Unit AG, Lettenweg 118, Allschwil (Basel), Switzerland
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Harald Labischinski
1MerLion Pharmaceuticals GmbH, Robert-Rössle Strasse 10, Berlin, Germany
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DOI: 10.1128/AAC.00832-10
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ABSTRACT

Finafloxacin is a new fluoroquinolone antibiotic with the unique property of increasing antibacterial activity at pH values lower than neutral. Whereas its antibacterial activity at neutral pH matches that of other quinolones in clinical use, it is expected to surpass this activity in tissues and body fluids acidified by the infection or inflammation processes. Pharmacokinetic parameters of oral single and multiple doses of up to 800 mg of finafloxacin and safety/tolerability observations were assessed in a phase I study including 95 healthy volunteers. Finafloxacin is well absorbed after oral administration, generating maximum concentrations (Cmaxs) in plasma at least comparable to those of other fluoroquinolones, with a half-life of around 10 h. About one-third of the dose is excreted unchanged in the urine. Renal elimination appears to be a saturable process leading to slight increases of the area under the concentration-time curve extrapolated to infinity and dose normalized (AUC∞,norm) at dosages of 400 mg and above. Safety and tolerability data characterize finafloxacin as a drug with a favorable safety profile. In particular, adverse reactions regarded as class-typical of fluoroquinolones, such as, e.g., electrocardiogram (ECG) changes, neurotoxic effects, or hypoglycemia, were not observed in the study population.

FOOTNOTES

    • Received 18 June 2010.
    • Returned for modification 19 March 2011.
    • Accepted 4 June 2011.
    • Accepted manuscript posted online 27 June 2011.
  • ↵† This publication is dedicated to Harald Labischinski, who sadly died unexpectedly in August 2010.

  • Copyright © 2011, American Society for Microbiology. All Rights Reserved.
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Human Pharmacokinetics and Safety Profile of Finafloxacin, a New Fluoroquinolone Antibiotic, in Healthy Volunteers
Heena Patel, Arne Andresen, Andreas Vente, Hans-Dietrich Heilmann, Will Stubbings, Michael Seiberling, Luis Lopez-Lazaro, Rolf Pokorny, Harald Labischinski
Antimicrobial Agents and Chemotherapy Aug 2011, 55 (9) 4386-4393; DOI: 10.1128/AAC.00832-10

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Human Pharmacokinetics and Safety Profile of Finafloxacin, a New Fluoroquinolone Antibiotic, in Healthy Volunteers
Heena Patel, Arne Andresen, Andreas Vente, Hans-Dietrich Heilmann, Will Stubbings, Michael Seiberling, Luis Lopez-Lazaro, Rolf Pokorny, Harald Labischinski
Antimicrobial Agents and Chemotherapy Aug 2011, 55 (9) 4386-4393; DOI: 10.1128/AAC.00832-10
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