A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
研究概览
简要总结
This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).
详细描述
This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06651600 after multiple oral doses of 50 mg daily. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 11 will be a maximum of 39 days and from Screening visit to Follow-up/Contact Visit will a maximum of 73 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of >/= 17.5 to </= 40.0 kg/m2; and a total body weight > 50 kg (110 lb)
- •Additional inclusion criteria for subjects with renal impairment:
- •Meet the following eGFR criteria during the screening period based upon MDRD equation:
- •Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis
- •Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min
- •Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min
- •Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included)
- •Stable drug regimen
排除标准
- •Females of child-bearing potential must use an accepted, highly effective contraceptive method
- •Renal transplant recipients
- •Urinary incontinence without catheterization
- •Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
- •Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ
- •HIV, Hepatitis B, or Hepatitis C infection
- •Additional exclusion criteria for subjects with renal impairment:
- •Subjects requiring hemodialysis and peritoneal dialysis
- •Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)
- •Screening 12-lead ECG demonstrating QTcF >470 msec
研究组 & 干预措施
PF-06651600 Severe Renal Impairment
This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
干预措施: PF-06651600 (Drug)
PF-06651600 Normal Renal Function
This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
干预措施: PF-06651600 (Drug)
PF-06651600 Moderate Renal Impairment
This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
干预措施: PF-06651600 (Drug)
PF-06651600 Mild Renal Impairment
This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.
干预措施: PF-06651600 (Drug)
结局指标
主要结局
Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
时间窗: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.
Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
时间窗: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
The plasma PF-06651600 Cmax was observed directly from data.
次要结局
- Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria(At screening, on Day -1, Day 11 and early termination/discontinuation.)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.)
- Number of Participants With Laboratory Abnormalities(At Screening Visit 1 and on Days -1, 5, 11 and early termination day.)
- Number of Participants With Vital Signs Data Meeting Pre-specified Criteria(At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.)