Multiple-dose safety and pharmacokinetics of oral garenoxacin in healthy subjects

Antimicrobial Agents and Chemotherapy

Volumn 47, Issue 7, 2003, Pages 2256-2263

  Gajjar, D A ^a,b   Bello, A ^a   Ge, Z ^a   Christopher, L ^a   Grasela, D M ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GARENOXACIN; PLACEBO; QUINOLINE DERIVED ANTIINFECTIVE AGENT; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ANTIBIOTIC THERAPY; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; EPIGASTRIC PAIN; FATIGUE; FECES MICROFLORA; FEMALE; HEADACHE; HELICOBACTER PYLORI; HUMAN; HUMAN EXPERIMENT; LETHARGY; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MEAN RESIDENCE TIME; NORMAL HUMAN; PRIORITY JOURNAL; PSYCHOMETRY; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; SORE THROAT; TONGUE DISEASE; VOMITING;

ADMINISTRATION, ORAL; ADULT; ELECTROCARDIOGRAPHY; FLUOROQUINOLONES; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; INDOLES; PLACEBOS; PSYCHOMETRICS; QUINOLONES;

EID: 0037974633     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.47.7.2256-2263.2003     Document Type: Article

References (24)

1. Applebaum, P. C. 1999. Quinolone activity against anaerobes. Drugs 58 (Suppl. 2):60-64.
2. Ball, P., L. Mandell, Y. Niki, and G. Tillotson. 1999. Comparative tolerability of the newer floroquinolone antibacterials. Drug Saf. 21:407-421.
3. Bazett, H. C. 1920. An analysis of the time relations of electrocardiograms. Heart 7:353-370.
4. Bebear, C. M., J. Renaudin, A. Charron, H. Renaudin, B. de Barbeyrac, T. Schaeverbeke, and C. Bebear. 1999. Mutations in the gyrA, parC, and parE genes associated with fluoroquinolone resistance in clinical isolates of Mycoplasma hominis. Antimicrob. Agents Chemother. 43:954-956.
5. Bertino, J., Jr., and D. Fish. 2000. The safety profile of the fluoroquinolones. Clin. Ther. 22:798-817.
6. Blondeau, J. M. 1999. Expanded activity and utility of the new fluoroquinolones: a review. Clin. Ther. 21:3-40.
7. Chiba, K., A. Sugiyama, Y. Satoh, H. Shiina, and K. Hashimoto. 2000. Proarrhythmic effects of fluoroquinolone antibacterial agents: in vivo effects as physiologic substrate for torsades. Toxicol. Appl. Pharmacol. 169:8-16.
8. Efthymiopoulos, C., S. L. Bramer, and A. Maroli. 1997. Pharmacokinetics of grepafloxacin after oral administration of single and repeat doses in healthy young males. Clin. Pharmacokinet. 33(Suppl. 1):1-8.
9. Fung-Tomc, J. C., B. Minassian, B. Kolek, E. Huczko, L. Aleksunes, T. Stickle, T. Washo, E. Gradelski, L. Valera, and D. P. Bonner. 2000. Antibacterial spectrum of a novel des-fluoro(6) quinolone, BMS-284756. Antimicrob. Agents Chemother. 44:3351-3356.
10. Hoellman, D. B., L. M. Kelly, M. R. Jacobs, and P. C. Applebaum. 2001. Comparative antianaerobic activity of BMS 284756. Antimicrob. Agents Chemother. 45:589-592.
11. Jones, R. N., and M. A. Pfaller. 2000. In vitro activity of newer fluoroquinolones for respiratory tract infections and emerging patterns of antimicrobial resistance: data from the SENTRY Antimicrobial Surveillance Program. Clin. Infect. Dis. 31(Suppl. 2):S516-S523.
12. Jones, R. N., M. A. Pfaller, and M. Stilwell. 2001. Activity and spectrum of BMS 284756, a new des-F (6) quinolone, tested against strains of ciprofloxacin-resistant Gram-positive cocci. Diagn. Microbiol. Infect. Dis. 39:133-135.
13. Lewis, M. T., A. C. Gales, H. S. Sader, M. A. Pfaller, R. N. Jones, and the SENTRY Participants Group (Latin America). 2000. Frequency of occurrence and antimicrobial susceptibility patterns for pathogens isolated from Latin American patients with a diagnosis of pneumonia: results from the SENTRY antimicrobial surveillance program (1998). Diagn. Microbiol. Infect. Dis. 37:63-74.
14. Lipsky, B. A., and C. A. Baker. 1999. Fluoroquinolone toxicity profiles: a review focusing on newer agents. Clin. Infect. Dis. 28:352-364.
15. Lubasch, A., I. Keller, K. Borner, P. Koeppe, and H. Lode. 2000. Comparative pharmacokinetics of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, trovafloxacin, and moxifloxacin after single oral administration in healthy volunteers. Antimicrob. Agents Chemother. 44:2600-2603.
16. Nord, C. E., D. A. Gajjar, and D. M. Grasela. 2002. Ecological impact of the des-F(6)-quinolone, BMS-284756, on the normal intestinal microflora. Clin. Microbiol. Infect. 8:229-239.
17. Patmore, L., S. Fraser, D. Mair, and A. Templeton. 2000. Effects of sparfloxacin, grepafloxacin, moxifloxacin, and ciprofloxacin on cardiac action potential duration. Eur. J. Pharmacol. 406:449-452.
18. Payton, C. D., J. G. Fox, N. F. Pauleau, J. M. Boulton-Jones, C. Loannides, A. Johnston, and P. Thomas. 1987. The single dose pharmacokinetics of bisoprolol (10 mg) in renal insufficiency: the clinical significance of balance clearance. Eur. Heart J. 8(Suppl. M):15-22.
19. Sader, H. S., R. N. Jones, A. C. Gales, P. Winokur, K. C. Kugler, M. A. Pfaller, G. V. Doern, and the SENTRY Latin American Study Group. 1998. Antimicrobial susceptibility patterns for pathogens isolated from patients in Latin American medical centers with a diagnosis of pneumonia: analysis of results from the SENTRY Antimicrobial Surveillance Program (1997). Diagn. Microbiol. Infect. Dis. 32:289-301.
20. SENTRY Participants Group (Latin America), A. Gales, H. Sader, and R. N. Jones. 2001. Activities of BMS 284756 (T-3811) against Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae isolates from SENTRY Antimicrobial Surveillance Program medical centers in Latin America (1999). Antimicrob. Agents Chemother. 45:1463-1466.
21. Stahlmann, R., and H. Lode. 1999. Toxicity of quinolones. Drugs 58(Suppl. 2):37-42.
22. Takahata, M., J. Mitsuyama, Y. Yamashiro, M. Yonezawa, H. Araki, Y. Todo, S. Minami, Y. Watanabe, and H. Narita. 1999. In vitro and in vivo antimicrobial activities of T-3811ME, a novel des-F(6)-quinolone. Antimicrob. Agents Chemother. 43:1077-1084.
23. Takahata, M., M. Shimakura, R. Hori, K. Kizawa, Y. Todo, S. Minami, Y. Watanabe, and H. Narita. 2001. In vitro and in vivo efficacies of T-3811ME (BMS-284756) against Mycoplasma pneumoniae. Antimicrob. Agents Chemother. 45:312-315.
24. Turnídge, J. 1999. Pharmacokinetics and pharmacodynamics of fluoroquinolones. Drugs 58(Suppl. 2):29-36.