A PHASE 1, NON-RANDOMIZED, OPEN LABEL, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-06700841 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
研究概览
简要总结
The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.
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-06700841 after a single oral dose of 30 mg. 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 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 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
- Other
- 盲法
- None
盲法说明
No Masking
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
- •Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
- •Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.
- •Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
- •Stable drug regimen
排除标准
- •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 to first dose
- •Known history of pulmonary embolism or recurrent deep vein thrombosis
- •Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
研究组 & 干预措施
PF-06700841 Severe Renal Impairment
This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1
干预措施: PF-06700841 (Drug)
PF-06700841 Normal Renal Function
This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1
干预措施: PF-06700841 (Drug)
PF-06700841 Moderate Renal Impairment
This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1
干预措施: PF-06700841 (Drug)
PF-06700841 Mild Renal Impairment
This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1
干预措施: PF-06700841 (Drug)
结局指标
主要结局
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
次要结局
- Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities(0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4)
- Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality(Baseline (Day -1) and Day 4)
- Number of Participants With Post-baseline Vital Sign Abnormalities(Baseline (Day 1) and Day 4)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days))