E. Lawrence M. Bhavnani

194 SCIENTIFIC SESSIONS September 9-12 | A-1945 Standardization of a Murine Model of Systemic Candida albi- cans Infection to Study Therapeutic Equivalence TE of Flucon- azole FCZ Generics J. M. Gonzalez, M. Agudelo, L. M. Leiva, C. A. Rodriguez, O. Vesga; Univ. of Antioquia, Medellin, Colombia. A-1946 Maximal Use PK Study of Luliconazole Solution 10 in Subjects with Onychomycosis

A. Tavakkol

1 , T. Jones 2 ; 1 Topica Pharmaceuticals, Los Altos, CA, 2 J S Studies, Inc., College Station, TX. Late-breaker presentations are listed behind the Late-breaker tab of the Final Program. ------------------------------------------------------------------------ 241A Poster Session Toxicokinetics and PKPD of New and Old Fluoroquinolones Wednesday, 9:15 a.m.–11:15 a.m. . . . . . . . . . . . . . . . . . . . . . . . . . Halls A-C Presentations: A-1947 In Vivo Pharmacodynamic PD Characterization of a New Fluoroquinolone FQ Antibiotic, Kpi-10, against Gram-Positive GP and Gram-Negative GN Bacteria

A. Lepak, K. Marchillo, J. Cabezas, W. Craig, D. R. Andes; Univ. of Wis- consin, Madison, WI.

A-1948 Systemic Exposure Profile and Tissue Penetration Lung, Kidney, Bone Marrow, and Gallblader of KPI-10 in Rabbits After Intravenous Administration

C. Jacqueline

1 , V. Le Mabecque 1 , C. Desessard 2 , A. F. Miegeville 1 , Y. Ge 3 , G. Potel 1 , J. Caillon 1 ; 1 UPRES EA 3826, Nantes, France, 2 Atlangram, Nantes, France, 3 Kalidex Pharmaceuticals Inc., Menlo Park, CA. A-1949 Absorption, Excretion, Tissue Distribution, and Protein Binding of KPI-10, a New Broad-Spectrum Fluoroquinolone

Y. Ge

1 , P. B. Eckburg 1 , J. Enoru 2 , E. Solon 3 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 Ricerca Biosciences, LLC, Concord, OH, 3 QPS, LLC, Newark, DE. A-1950 In Vitro and In Vivo Metabolism of KPI-10, a New Broad- Spectrum Fluoroquinolone

Y. Ge

1 , P. B. Eckburg 1 , V. Jiang 1 , J. Enoru 2 , R. Mc Clanahan 2 , W. De Maio 2 , D. Johnson 3 , A. Kousba 3 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 Ricerca Biosciences, LLC, Concord, OH, 3 MicroConstants, Inc., San Diego, CA. A-1951 Effect of KPI-10, a Novel, Broad-Spectrum Fluoroquino- lone, on the Activity of Cytochrome P450 Isoenzymes in Human Hepatocytes

J. Ge

1 , P. B. Eckburg 1 , J. Enoru 2 , W. DeMaio 2 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 Ricerca Biosciences, LLC, Concord, OH. A-1952 Safety Pharmacokinetics of KPI-10, a Novel Fluoroquinolone, in Healthy Adults Receiving Single Dose Oral Administrations

P. B. Eckburg

1 , Y. Ge 1 , V. Jiang 1 , T. Kilfoil 2 , G. H. Talbot 3 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 InClin, Inc., Los Altos, CA, 3 Talbot Advisors LLC, Anna Maria, FL. A-1953 Permeability and Pharmacokinetics PK of Intravenous IV and Oral PO KPI-10, a Novel Broad-Spectrum Fluoroquino- lone FQ

Y. Ge

1 , P. B. Eckburg 1 , V. Jiang 1 , D. Freeman 2 , A. Kousba 3 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 Ricerca Biosciences, LLC, Concord, OH, 3 MicroConstants, Inc., San Diego, CA. A-1954 Repeat-Dose Toxicity and Toxicokinetics TK of Oral KPI- 10, a Novel Fluoroquinolone, in Rats and Dogs

P. B. Eckburg

1 , Y. Ge 1 , L. Donald 2 ; 1 Kalidex Pharmaceuticals, Inc., Menlo Park, CA, 2 Intertek Cantox, Hoover, AL. A-1955 Lack of In Vitro or In Vivo Phototoxicity Associated with KPI-10, a New Broad-Spectrum Fluoroquinolone

P. B. Eckburg

1 , Y. Ge 1 , K. Yasuhiro 2 , D. B. Learn 3 ; 1 Kalidex Pharmaceuti- cals, Inc., Menlo Park, CA, 2 Wakunaga Pharmaceutical Co., Ltd., Hiroshima, Japan, 3 Charles River Lab., Horsham, PA. A-1956 Metabolism and Mass Balance of Delafloxacin in Healthy Human Volunteers Following Intravenous Administration A. McEwen 1 , L. Lawrence 2 , S. Wood 1 , G. Ford 1 , J. Longcor 2 , D. Li 2 , M. Reeve 2 , R. Hoover 2 ; 1 Quotient Bioresearch, Rushden, United Kingdom, 2 Rib-X Pharmaceuticals, New Haven, CT. A-1957 Pharmacokinetics PK of Delafloxacin DLX, Vancomycin VAN, and Linezolid LNZ in a Phase 2 Exploratory Study in Subjects with Acute Bacterial Skin and Skin Structure Infections ABSSSI

R. Hoover

1 , L. Lawrence 1 , J. Longcor 1 , J. Greenfield 2 ; 1 Rib-X Pharmaceu- ticals, New Haven, CT, 2 PharmaNeti3, The Woodlands, TX. A-1958 A Thorough Phase 1 QTc Study of Delafloxacin DLX Compared with Placebo and Moxifloxacin MXF

L. E. Lawrence

1 , M. Benedict 2 , M. Medlock 2 , J. Litwin 3 , M. Thorn 4 , S. Hopkins 1 , J. Longcor 1 ; 1 Rib-X Pharmaceuticals Inc., New Haven, CT, 2 PPD Phase 1 Clinic, Austin, TX, 3 ERT, Philadelphia, PA, 4 Statistical Resources, Chapel Hill, NC. A-1959 Comparison of Postantibiotic Effects of Finafloxacin and Other Fluoroquinolones C. Y. Goh 1 , S. B. Ng 1 , M. J. Everett 1 , A. Vente 2 ; 1 MerLion Pharmaceuticals Pte Ltd, Singapore, Singapore, 2 MerLion Pharmaceuticals GmbH, Berlin, Germany. A-1960 A Phase I Study to Determine Safety, Tolerability and Pharmacokinetics PK of Intravenous Doses of Finafloxacin HCl FIN in Healthy Subjects M. Lückermann, L. Mooney, H. Patel, C. Fischer, S. Wohlert, A. Vente; MerLion Pharmaceuticals GmbH, Berlin, Germany. A-1961 Population Pharmacokinetic PPK and Pharmacokinetic Pharmacodynamic PKPD Target Attainment TA Analyses to Support JNJ-Q2 Dose Selection for Patients with Acute Bacterial Skin and Skin Structure Infections ABSSSI S. A. Van Wart 1 , M. Melhem 1 , J. M. Davenport 2 , P. G. Ambrose 1 , S. M. Bhavnani 1 , D. R. Andes 3 , W. A. Craig 3 , G. F. Mc Intyre 2 , C. M. Rubino 1 ; 1 ICPD, Latham, NY, 2 Furiex Pharmaceuticals, Morrisville, NC, 3 Univ. of Wisconsin, Madison, WI. 195 WEDNESDAY SCIENTIFIC SESSIONS Final Program A-1962 PharmacokineticPharmacodynamic PKPD Analysis for Efficacy of JNJ-Q2 Using Phase 2 Data from Patients with Acute Bacterial Skin and Skin Structure Infections ABSSSI

S. M. Bhavnani

1 , J. P. Hammel 1 , S. A. Van Wart 1 , M. Melhem 1 , C. M. Rubino 1 , J. M. Davenport 2 , G. F. Mc Intyre 2 , P. G. Ambrose 1 ; 1 ICPD, Latham, NY, 2 Furiex Pharmaceuticals, Morrisville, NC. A-1963 Decrease of Levofloxacin Fecal Concentrations in Experi- mental Dogs Using DAV132, an Oral Adsorbent Delivered to the IleumColon S. Sayah-Jeanne 1 , E. Chachaty 2 , T. Nguyen 3,4 , V. Augustin 1 , J. de Gunz- burg 1 , F. Mentré 3,4 , A. Andremont 5,6 ; 1 Da Volterra, Paris, France, 2 Institut Gustave-Roussy, Villejuif, France, 3 UMR738 INSERM, Paris, France, 4 Univ. Paris Diderot, Paris, France, 5 EA 3964 Univ. Paris Diderot, Paris, France, 6 Hosp. Bichat, AP-HP, Paris, France. A-1964 Levofloxacin LVX Penetration into Epithelial Lining Fluid ELF Differs Between Infected and Uninfected Patients

J. L. Kuti, D. P. Nicolau; Ctr. for Anti-Infect. Res. Dev., Hartford Hosp., Hartford, CT.