A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 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
- Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
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 Pharmacokinetic (PK) of PF-06882961
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
- Single (Participant)
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
- •Male and female participants between the ages of 18 (or the minimum country-specific age of consent if >18) and 70 years, inclusive, at the screening visit:
- •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 38.0 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.
排除标准
- •Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening;
- •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;
- •A positive COVID-19 test at screening;
- •A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study;
- •Use of prior/concomitant therapies
- •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-06882961;
- •Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- •HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;
- •A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;
- •At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;
- •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;
- •History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections;
- •Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
研究组 & 干预措施
PF-06882961 participants without Hepatic Impairment
This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1
干预措施: PF-06882961 20MG (Drug)
PF-06882961 participants with mild Hepatic Impairment
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
干预措施: PF-06882961 20MG (Drug)
PF-06882961 participants with moderate Hepatic Impairment
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
干预措施: PF-06882961 20MG (Drug)
PF-06882961 participants with severe Hepatic Impairment
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
干预措施: PF-06882961 20MG (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
时间窗: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.
Maximum Plasma Concentration (Cmax)
时间窗: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Maximum observed plasma PF-06882961 concentration.
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
时间窗: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Fraction of Unbound Drug in Plasma (fu)
时间窗: Predose (0 hours), and 4 hours post dose on Day 1.
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
次要结局
- Number of Participants Reporting Treatment-emergent Adverse Events (AEs)(Baseline to Day 30)
- Number of Participants With Clinical Laboratory Abnormalities(Baseline to Day 3)
- Number of Participants With Categorical Vital Signs Data(Baseline to Day 3)
- Number of Participants With Categorical Electrocardiogram (ECG) Data(Baseline to Day 3)