A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
研究概览
简要总结
The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream.
This study is seeking participants who are:
- Healthy male or female participants aged 18 years or older.
All participants in this study will receive PF-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522.
The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given.
Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms.
- •Body mass index of 16-32 kg/m2; and a total body weight >50 kg (110 lbs).
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).
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or participants with suspected MTC per the investigator's judgement.
- •Any 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 any prohibited prior/concomitant medication(s).
- •A positive urine drug test at screening or admission.
研究组 & 干预措施
Sequence 1
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 1
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 1
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
Sequence 2
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 2
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 2
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
Sequence 3
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 3
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 3
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
Sequence 4
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 4
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 4
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
Sequence 5
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 5
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 5
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
Sequence 6
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 IR (Formulation 1) (Drug)
Sequence 6
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 2) (Drug)
Sequence 6
Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as:
Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
干预措施: PF-06954522 MR (Formulation 3) (Drug)
结局指标
主要结局
Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
时间窗: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
时间窗: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period
次要结局
- Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to the fasted state.(0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period)
- Number of Participants with Treatment-Emergent Adverse Events (AEs)(From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1)
- Number of Participants with Laboratory Test Abnormalities(From baseline up to 72 hours after PF-06954522 dose in each period)
- Number of Participants with Summary of Post-Baseline Vital Signs Data(From baseline up to 72 hours after PF-06954522 dose in each period)
- Number of Participants who met Defined Electrocardiogram (ECG) Criteria(From baseline up to 72 hours after PF-06954522 dose in each period)
- Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to fasted state.(0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period)