Tissue and fluid penetration of garenoxacin in surgical patients.

Background And Purpose: Garenoxacin is a novel des-F(6)-quinolone that exhibits broad-spectrum activity against a wide range of aerobic and anaerobic pathogens of clinical importance. This study examined the penetration of garenoxacin into sinus mucosa, incisional skin, subcutaneous tissue, bile, adipose tissue, striated muscle, bone, gallbladder wall, liver, small and large bowel mucosa, and mesenteric lymph nodes relative to the plasma concentration after an oral 600 mg dose.

Methods: A series of 30 patients, ages 20 to 83 years, undergoing elective surgery were enrolled.

Population pharmacokinetics and pharmacodynamics of garenoxacin in patients with community-acquired respiratory tract infections.

Garenoxacin (T-3811ME, BMS-284756) is a novel, broad-spectrum des-F(6) quinolone currently under study for the treatment of community-acquired respiratory tract infections. This analysis assessed garenoxacin population pharmacokinetics and exposure-response relationships for safety (adverse effects [AE]) and antimicrobial activity (clinical cure and bacteriologic eradication of Streptococcus pneumoniae and the grouping of Haemophilus influenzae, Haemophilus parainfluenzae, and Moraxella catarrhalis). Data were obtained from three phase II clinical trials of garenoxacin administered orally as 400 mg once daily for 5 to 10 days for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and sinusitis.

Characterization of the penetration of garenoxacin into the breast milk of lactating women.

The primary objective of this study was to characterize the extent of excretion of garenoxacin, a novel des-F(6)-quinolone antimicrobial, into the breast milk of lactating women. A secondary objective was to determine the time after dose administration that garenoxacin was no longer detected in breast milk so as to define when a mother may resume breastfeeding if it was interrupted for garenoxacin administration. Six healthy, lactating women (age [mean +/- SD]: 32 +/- 6 years; weight: 68.

Effect of a high-fat meal on the pharmacokinetics of the des-F(6)-quinolone BMS-284756.

Study Objective: To evaluate the effects of a high-fat meal on the systemic exposure of oral BMS-284756.

Design: Open-label, randomized, two-way crossover study.

Setting: Clinical research facility.