A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Time for Cmax (Tmax)
研究概览
简要总结
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
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
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects of non-childbearing potential between the ages of 21 and
- •No evidence of active or latent TB.
- •An informed consent document signed and dated by the subject.
排除标准
- •Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy) or any active GI disease (including any relevant surgery).
- •Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version
- •A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
- •Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •Other severe acute or chronic medical or psychiatric condition 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
Sequence 1
干预措施: PH-797804 material sparing tablet (Drug)
Sequence 1
干预措施: PH-797804 Phase2b/3 with sodium lauryl sulphate (Drug)
Sequence 2
干预措施: PH-797804 Phase2b/3 with sodium lauryl sulphate (Drug)
Sequence 2
干预措施: PH-797804 material sparing tablet (Drug)
Sequence 3
干预措施: PH-797804 material sparing tablet (Drug)
Sequence 3
干预措施: PH-797804 Phase2b/3 without sodium lauryl sulphate (Drug)
Sequence 4
干预措施: PH-797804 Phase2b/3 without sodium lauryl sulphate (Drug)
Sequence 4
干预措施: PH-797804 material sparing tablet (Drug)
Sequence 5
oral, 6mg, single dose
干预措施: PH-797804 Phase2b/3 without sodium lauryl sulphate (Drug)
Sequence 5
oral, 6mg, single dose
干预措施: PH-797804 Phase2b/3 with sodium lauryl sulphate (Drug)
Sequence 6
oral, 6mg, single dose
干预措施: PH-797804 Phase2b/3 with sodium lauryl sulphate (Drug)
Sequence 6
oral, 6mg, single dose
干预措施: PH-797804 Phase2b/3 without sodium lauryl sulphate (Drug)
结局指标
主要结局
Time for Cmax (Tmax)
时间窗: predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
时间窗: predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)
时间窗: predose to day 7 of treatment period
Terminal half-life (t1/2)
时间窗: predose to day 7 of treatment period
次要结局
未报告次要终点