A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Part B is a sponsor open, double blind study where the investigator, medical monitor and the participants will be blinded.
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 male and female participants between 18 -55 years of age.
- •BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- •Participants who are willing and able to comply with all scheduled visits, treatment
- •plan, laboratory tests, lifestyle considerations, and other study procedures.
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).
- •Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
- •History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
- •Positive urine drug test.
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours
研究组 & 干预措施
PF-06700841: IR, MR1, MR2, MR1_fed
Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: IR, MR1, MR2, MR1_fed
Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: IR, MR1, MR2, MR1_fed
Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841: MR1, MR2, IR, MR1_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: MR1, MR2, IR, MR1_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: MR1, MR2, IR, MR1_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841: MR2, IR, MR1, MR1_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: MR2, IR, MR1, MR1_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: MR2, IR, MR1, MR1_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841: IR, MR1, MR2, MR2_fed
Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: IR, MR1, MR2, MR2_fed
Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: IR, MR1, MR2, MR2_fed
Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841: MR1, MR2, IR, MR2_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: MR1, MR2, IR, MR2_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: MR1, MR2, IR, MR2_fed
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841: MR2, IR, MR1, MR2_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 IR (Drug)
PF-06700841: MR2, IR, MR1, MR2_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR1 (Drug)
PF-06700841: MR2, IR, MR1, MR2_fed
Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
干预措施: PF-06700841 MR2 (Drug)
PF-06700841 MR3 (Dose A) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
干预措施: PF-06700841 MR3 (Drug)
PF-06700841 MR3 (Dose A) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
干预措施: Placebo (Other)
PF-06700841 MR3 (Dose B) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
干预措施: PF-06700841 MR3 (Drug)
PF-06700841 MR3 (Dose B) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
干预措施: Placebo (Other)
PF-06700841 MR3 (Dose C) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition
干预措施: PF-06700841 MR3 (Drug)
PF-06700841 MR3 (Dose C) or matching placebo
Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition
干预措施: Placebo (Other)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
时间窗: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
时间窗: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
时间窗: Baseline to Day 10
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
时间窗: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
时间窗: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
次要结局
- Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1(pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1)
- Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1(pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7)
- Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7(pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7)
- Number of subjects with clinically relevant changes in vital signs in Part A(Pre-dose and 96 hours post dose)
- Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7(pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7)
- Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A(Pre-dose and 96 hours post dose)
- Number of participants with clinically relevant changes in clinical laboratory tests in Part A(Baseline and 96 hours post dose)
- Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A(Baseline to Day 4)
- Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1(pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1)
- Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7(pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7)
- Terminal half-life of PF-06700841 in Part B(pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7)