A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS 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
- Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) for rosuvastatin
研究概览
简要总结
Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period 2, after a washout period of at least 5 days, each subject will receive oral doses of tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3 to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants must be 18 to 60 years of age, inclusive, at the time of signing the informed consent document (ICD)
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •History of hypersensitivity to rosuvastatin., asymptomatic, seasonal allergies at the time of dosing).
- •Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg, rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
- •Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is longer) prior to dosing
研究组 & 干预措施
rosuvastatin and tafamidis fixed sequence
- Period 1: rosuvastatin 10 mg (single oral administration)
- Washout
- Period 2: tafamidis 61 mg capsule(multiple doses, twice a day) + rosuvastatin 10 mg (single oral administration)
干预措施: tafamidis (Drug)
rosuvastatin and tafamidis fixed sequence
- Period 1: rosuvastatin 10 mg (single oral administration)
- Washout
- Period 2: tafamidis 61 mg capsule(multiple doses, twice a day) + rosuvastatin 10 mg (single oral administration)
干预措施: rosuvastatin (Drug)
结局指标
主要结局
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) for rosuvastatin
时间窗: Hours 0, at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose in Periods 1 and 2.
AUClast + (Clast/kel)
Apparent renal clearance (CLr) for rosuvastatin
时间窗: Hours 0, at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose in Periods 1 and 2 for AUClast. For Ae, hours 0-24, 24-48, 48-72 hours post-dose in Periods 1 and 2.
Ae/AUClast for extravascular dosing
次要结局
- Number of subjects with a clinically significant change in laboratory tests from baseline(Baseline through Day 10 of period 2)
- Number of subjects with a clinically significant change in vital sign measurements from baseline(Baseline through Day 10 of period 2)
- Number of subjects with treatment emergent adverse events(Baseline through Day 28 follow up)