A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are 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 35.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.
- •Capable of giving signed informed consent.
- •Exclusion Criteria
- •Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
- •At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
- •Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
- •Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-
- •A positive urine drug test, for illicit drugs on Day -1,
- •At Screening or Day -1, a positive breath alcohol test.
- •Male participants with partners who are currently pregnant.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.
- •Unwilling or unable to comply with the criteria in the Lifestyle Considerations.
- •Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
排除标准
- 未提供
研究组 & 干预措施
PF-06865571 Moderate Hepatic Impairment
This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
干预措施: PF-06865571 100 mg (Drug)
PF-06865571 Severe Hepatic Impairment
This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
干预措施: PF-06865571 100 mg (Drug)
PF-06865571 Mild Hepatic Impairment
This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
干预措施: PF-06865571 100 mg (Drug)
PF-06865571 Healthy Participants
This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1
干预措施: PF-06865571 100 mg (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
Cmax of PF-06865571 was observed directly from data.
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
时间窗: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
时间窗: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to Day 32 (31 days after investigational product administration))
- Number of Participants With Clinical Laboratory Abnormalities(Up to Day 4 (3 days after investigational product administration))
- Number of Participants With Categorical Vital Signs Data(Up to Day 4 (3 days after investigational product administration))
- Number of Participants With Categorical Electrocardiogram (ECG)(Up to Day 4 (3 days after investigational product administration))