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Lack of phototoxicity potential with delafloxacin in healthy male and female subjects: comparison to lomefloxacin
Photochemical & Photobiological Sciences ( IF 2.7 ) Pub Date : 2018-04-27 00:00:00 , DOI: 10.1039/c8pp00019k R. S. Dawe 1, 2, 3, 4 , J. Ferguson 1, 2, 3, 4 , S. Ibbotson 1, 2, 3, 4 , L. Lawrence 5, 6, 7, 8 , S. Paulson 8, 9, 10 , E. Duffy 5, 6, 8, 11 , S. Cammarata 5, 6, 7, 8
Photochemical & Photobiological Sciences ( IF 2.7 ) Pub Date : 2018-04-27 00:00:00 , DOI: 10.1039/c8pp00019k R. S. Dawe 1, 2, 3, 4 , J. Ferguson 1, 2, 3, 4 , S. Ibbotson 1, 2, 3, 4 , L. Lawrence 5, 6, 7, 8 , S. Paulson 8, 9, 10 , E. Duffy 5, 6, 8, 11 , S. Cammarata 5, 6, 7, 8
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Aims: Delafloxacin is a fluoroquinolone antibiotic recently approved by the FDA for treatment of acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin was assessed for phototoxicity potential compared with a known phototoxic fluoroquinolone. Methods: A Phase 1, investigator-blind, placebo/active-controlled, randomized, parallel-group study was conducted in 52 healthy male and female volunteers who received 200 or 400 mg of oral delafloxacin, 400 mg oral lomefloxacin or placebo once daily for 6 days. This study evaluated the photosensitizing potential and possible wavelength dependency of delafloxacin by comparing the response of the skin to ultraviolet A (UVA), ultraviolet B (UVB) and visible radiation prior to and during administration of delafloxacin, lomefloxacin as a positive control, or placebo. Adverse events were monitored throughout the study. Results: Forty-seven subjects completed six days of dosing, and no evidence of phototoxicity was seen with delafloxacin. Delafloxacin at 200 and 400 mg day−1 and placebo did not demonstrate differences in percent change from baseline in minimal erythema dose at all tested wavelengths (295–430 nm) by monochromator and solar simulator. Lomefloxacin, the positive control, had statistically significant differences (p < 0.05) at UVA wavelengths of 335 and 365 ± 30 nm 24 hours after radiation exposure (maximum response). The phototoxic index results were significantly higher for lomefloxacin at 335 nm and 365 nm compared to placebo and delafloxacin. Conclusions: 200 and 400 mg of delafloxacin administered for 6 days were well tolerated in healthy adult volunteers. Delafloxacin and placebo failed to demonstrate a phototoxic effect but lomefloxacin, the positive control, demonstrated moderate phototoxicity.
中文翻译：
地氟沙星在健康男性和女性受试者中缺乏光毒性的潜力：与洛美沙星的比较
目的：德拉福沙星是一种氟喹诺酮抗生素，最近被FDA批准用于治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）。与已知的光毒性氟喹诺酮类药物相比，评估了Delafloxacin的光毒性潜力。方法：在52位健康的男性和女性志愿者中进行了1期研究，盲人，安慰剂/活性对照，随机分组的平行研究，他们每天接受200或400毫克口服地拉氟沙星，400毫克口服洛美沙星或安慰剂，共6次天。这项研究通过比较在服用德拉福沙星，洛美沙星作为阳性对照或安慰剂之前和期间，皮肤对紫外线A（UVA），紫外线B（UVB）和可见辐射的响应，从而评估了德拉福沙星的光敏潜力和可能的波长依赖性。 。在整个研究过程中监测不良事件。结果：47名受试者完成了为期6天的给药，并没有观察到地氟沙星的光毒性迹象。Delafloxacin 200和400 mg每天-1安慰剂未显示单色仪和太阳模拟器在所有测试波长（295-430 nm）下最小红斑剂量与基线的变化百分比差异。阳性对照洛美沙星在辐射暴露后24小时的335和365±30 nm的UVA波长下具有统计学上的显着差异（p <0.05）。与安慰剂和地拉沙星相比，洛美沙星在335 nm和365 nm处的光毒性指数结果显着更高。结论：200毫克和400毫克地拉氟沙星分别在6天中服用，对健康的成年人志愿者具有良好的耐受性。Delafloxacin和安慰剂未能显示出光毒性作用，但阳性对照洛美沙星显示出中等的光毒性。
更新日期：2018-04-27
中文翻译：
地氟沙星在健康男性和女性受试者中缺乏光毒性的潜力：与洛美沙星的比较
目的：德拉福沙星是一种氟喹诺酮抗生素，最近被FDA批准用于治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）。与已知的光毒性氟喹诺酮类药物相比，评估了Delafloxacin的光毒性潜力。方法：在52位健康的男性和女性志愿者中进行了1期研究，盲人，安慰剂/活性对照，随机分组的平行研究，他们每天接受200或400毫克口服地拉氟沙星，400毫克口服洛美沙星或安慰剂，共6次天。这项研究通过比较在服用德拉福沙星，洛美沙星作为阳性对照或安慰剂之前和期间，皮肤对紫外线A（UVA），紫外线B（UVB）和可见辐射的响应，从而评估了德拉福沙星的光敏潜力和可能的波长依赖性。 。在整个研究过程中监测不良事件。结果：47名受试者完成了为期6天的给药，并没有观察到地氟沙星的光毒性迹象。Delafloxacin 200和400 mg每天-1安慰剂未显示单色仪和太阳模拟器在所有测试波长（295-430 nm）下最小红斑剂量与基线的变化百分比差异。阳性对照洛美沙星在辐射暴露后24小时的335和365±30 nm的UVA波长下具有统计学上的显着差异（p <0.05）。与安慰剂和地拉沙星相比，洛美沙星在335 nm和365 nm处的光毒性指数结果显着更高。结论：200毫克和400毫克地拉氟沙星分别在6天中服用，对健康的成年人志愿者具有良好的耐受性。Delafloxacin和安慰剂未能显示出光毒性作用，但阳性对照洛美沙星显示出中等的光毒性。
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