NCT03092232已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06865571 In Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy males and female of non-childbearing potential;
- •Age of 18-55, inclusive;
- •Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
- •Body weight >50 kg;
- •Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
排除标准
- •Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug test.
- •History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- •Treatment 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 (whichever is longer).
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- •History of sensitivity to heparin or heparin induced thrombocytopenia.
- •History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- •Subjects 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: (1)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) level, or total bilirubin > upper limit of normal (ULN); (2) For optional Cohort 3 only, AST or ALT greater or equal to 1.5 × ULN, provided that data from Cohorts 1 and 2 support this limit; (3) • Subjects 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 less than or equal to ULN plus ALT and AST are less than or equal to ULN plus alkaline phosphatase, hemoglobin, and reticulocyte count are all less than or equal to ULN.
- •Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
- •Subjects who are 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 subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- •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 subject inappropriate for entry into this study.
研究组 & 干预措施
Cohort 1_Active and Matching Placebo
Experimental
干预措施: Placebo (Drug)
Cohort 1_Active and Matching Placebo
Experimental
干预措施: PF-06865571 (Drug)
Cohort 2_Active and Matching Placebo
Experimental
干预措施: PF-06865571 (Drug)
Cohort 2_Active and Matching Placebo
Experimental
干预措施: Placebo (Drug)
Cohort 3_Active and Matching Placebo
Experimental
干预措施: PF-06865571 (Drug)
Cohort 3_Active and Matching Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: Screening up to 35 days after last dose of study medication
Number of participants with reported adverse events
Number of subjects with laboratory tests findings of potential clinical importance
时间窗: Baseline (Day 0) up to 14 days after last dose of study medication
Number of participants with potentially clinically important laboratory test findings
Number of subjects with vital signs findings of potential clinical importance
时间窗: Baseline (Day 0) up to 14 days after last dose of study medication
Number of participants with potentially clinically important vital sign measurements
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
时间窗: Baseline (Day 0) up to 14 days after last dose of study medication
Number of participants with potentially clinically important ECG findings
次要结局
- Dose normalized AUClast for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Dose normalized Cmax for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Time to Reach Maximum Observed Concentration for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Plasma Decay Half-Life (t1/2) for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Apparent Oral Clearance (CL/F) for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Apparent Volume of Distribution (Vz/F) for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Dose normalized AUCinf for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
- Maximum Observed Plasma Concentration (Cmax) for PF-06865571(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Single Dose Study of PF-06815345 in Healthy SubjectsHypercholesterolemiaNCT02654899Pfizer25
终止
1 期
Topical Multiple Ascending Dose Study for PF-06423264Normal HealthyNCT02778477Pfizer65
已完成
1 期
First in Human Study for PF-06667272HealthyNCT03126149Pfizer16
已完成
1 期
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult ParticipantsHealthy ParticipantsNCT04628793Pfizer29
已完成
1 期
CyPep-1 in Cutaneous WartsCutaneous WartsNCT03846648Centre for Human Drug Research, Netherlands56