A 2-PART, PHASE 1, OPEN LABEL STUDY WITH A 4-PERIOD, 4-SEQUENCE, CROSSOVER DESIGN IN COHORT 1 AND A 2-PERIOD, 2-SEQUENCE CROSSOVER DESIGN IN COHORT 2 TO COMPARE THE SINGLE DOSE PHARMACOKINETICS OF FIVE DIFFERENT FORMULATIONS OF PF-06882961 ADMINISTERED ORALLY TO OTHERWISE HEALTHY ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY

Pfizer1 个研究点分布在 1 个国家目标入组 31 人开始时间: 2020年11月4日最近更新: 2022年4月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 31
试验地点: 1
主要终点: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and E cohort 2

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Crossover
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

•Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
•Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study.
•Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
•A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit.
•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol.

排除标准

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
•Any condition possibly affecting drug absorption (eg, gastrectomy).
•History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg, HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed.
•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 prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention.
•Use of hormone replacement therapy or oral/injectable contraceptives.
•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 study intervention 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.
•Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
•Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
•Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
•Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.25 × upper limit of normal (ULN);
•Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
•HbA1c ≥6.5%;
•Fasting blood glucose ≥126 mg/dL (7 mmol/L);
•Calcitonin > ULN;
•eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.

研究组 & 干预措施

Formulation A (Cohort 1)

Active Comparator

Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed