SCH52000--EFFECTS OF IL10 ON CYTOCHROME P450 ENZYMES

SCH52000--IL10 对细胞色素 P450 酶的影响

• 批准号: 6117800
• 负责人: BARBARA HAEHNER
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6117800
• 关键词: clinical research; cytochrome P450; drug metabolism; enzyme activity; human subject; interleukin 10

The primary objective of the study is to determine the effects of Interleukin-10 on the Cytochrome P450 enzymes 1A1/2, 2D6, 3A4, and 2C8/9 using the metabolic products of caffeine, dextromethorphan, midazolam, and tolbutamide as markers. The secondary objective is to evaluate the safety and tolerance of IL-10 when administered as a subcutaneous injection a daily for a six day period at a dose of 8ug/kg. Up to 12 healthy, non- smoking, 18-45 year old males will complete this randomized, double-blind, multiple dose, two period crossover pharmacokinetic study. On Day 1 dubjects will be hospitalized and randomized for the crossover order of receiving IL-10 or placebo. The patient will receive either the IL-10 or placebo by subcutaneous injection on days 1-6. The subjects will receive IL-10 for the duration of an entire treatment period and will receive the placebo for the duration of an entire treatment period as outlined in the randomization schedule. On day 4 of both treatment periods tolbutamide, caffeine, and dextrohethorphan will be administered orally. On day 5 of both treatment periods midazolam will be administered by IV infusion. The morning of Day 7 patients will be discharged from the hospital. Following at least a 14 day washout period the patient will return for the second treatment period which will be identical to the first. The patient will again return on day 29 of treatment period two to have a blood sample drawn.

该研究的主要目的是确定 细胞色素P450酶1A1/2、2d6、3A4和2C8/9上的白介素-10 使用咖啡因的代谢产物，右美沙芬，咪达唑仑和 托尔丁酰胺作为标记。 次要目标是评估安全性 当作为皮下注射A给药时，IL-10的耐受性 每天六天，剂量为8盎司/千克。 多达12个健康，非 - 吸烟，18-45岁的男性将完成这一随机，双盲， 多剂量，两个时期的跨界药代动力学研究。 在第1天 Dubjects将住院并随机分配 接收IL-10或安慰剂。 患者将接受IL-10或 通过皮下注射安慰剂在第1-6天。 受试者将收到 IL-10在整个治疗期间，将获得 安慰剂在整个治疗期间的持续时间 随机时间表。 在两个治疗期的第4天TOLBUTAMIDE， 咖啡因和右旋甲虫将口服给药。 在第5天 两个治疗期咪达唑仑将通过IV输注施用。 这 第7天的早晨将从医院出院。 下列的 至少14天的洗涤期患者将返回第二次 治疗期将与第一个相同。 病人会 在治疗期的第29天再次返回，有一个血液样本 绘制。