A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 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
- Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600
研究概览
简要总结
This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.
This is an open-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.
Participants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.
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
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
排除标准
- •Evidence of congestive heart failure or history of congestive heart failure or any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident including transient ischemic attack or pulmonary embolus.
- •Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.
- •Infection with Hepatitis B, C or HIV
- •Known present or 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 treatment arm
This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole
干预措施: PF-06651600 10 mg tablets (Drug)
PF-06651600 treatment arm
This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole
干预措施: Itraconazole Solution 200 mg (Drug)
结局指标
主要结局
Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.
Maximum observed plasma concentration of PF-06651600
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
Peak concentration of PF-06651600
次要结局
- Incidence of treatment-emergent adverse events (AEs)(Baseline up to 35 days)
- Number of adverse events leading to discontinuation(Baseline up to 35 days)
- Number of participants with clinically significant change in vital signs from Baseline(Baseline to Day 9)
- Number of participants with clinically significant abnormalities in clinical laboratory values(Baseline to Day 9)