A PHASE 1, 2-PERIOD FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Renal clearance (CLr) for rosuvastatin
研究概览
简要总结
A phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
- •Body mass index (BMI) of 17.5 to 30.5 kg/m sq, and a total body weight greater than 50 kg (110 lb.).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Participants with any of the following acute or chronic infections or infection history:
- •Any infection requiring treatment within 2 weeks prior to the dosing visit.
- •Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days of the first dose of rosuvastatin.
- •Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of rosuvastatin.
- •Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
- •History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
- •Known presence or a history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
研究组 & 干预措施
PF-06651600 and Rosuvastatin
Period 1 is 4 days in length. On Day 1 of Period 1 participants will receive a single dose of Rosuvastatin 10 mg given as a tablet orally. Period 2 is 11 days in length and will immediately follow Period 1 with no washout. In Period 2, participants will be dosed with oral 200 mg PF-06651600 once-daily (QD) for 7 days. On Day 8 of Period 2, a single dose of 10 mg Rosuvastatin oral tablet will be administered following administration of the 200-mg dose of PF-06651600. Dosing with oral 200 mg PF-06651600 QD will continue until Day 10 of Period 2.
干预措施: PF-06651600 (Drug)
PF-06651600 and Rosuvastatin
Period 1 is 4 days in length. On Day 1 of Period 1 participants will receive a single dose of Rosuvastatin 10 mg given as a tablet orally. Period 2 is 11 days in length and will immediately follow Period 1 with no washout. In Period 2, participants will be dosed with oral 200 mg PF-06651600 once-daily (QD) for 7 days. On Day 8 of Period 2, a single dose of 10 mg Rosuvastatin oral tablet will be administered following administration of the 200-mg dose of PF-06651600. Dosing with oral 200 mg PF-06651600 QD will continue until Day 10 of Period 2.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Renal clearance (CLr) for rosuvastatin
时间窗: Period 1 (4 days) day 1 and period 2 (11 days) day 8 , hours: [0-6], [6-12], [12-24], [24-48], and [48-72] post-dose
CLr = total amount of drug collected in urine (Ae) divided by area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast).
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rosuvastatin
时间窗: Period 1 (4 days) day 1 and period 2 (11 days) day 8 , 0 (pre-dose), 0.5, 1,2,3,4,5,6,8,10,12,16,24,36,48,and 72 hours post-dose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
次要结局
未报告次要终点