A PHASE 1, OPEN-LABEL, RANDOMIZED, FIXED-SEQUENCE, PARALLEL-COHORT STUDY TO ESTIMATE THE EFFECT OF FLUVOXAMINE OR FLUCONAZOLE, ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF A SINGLE DOSE OF PF-04965842 IN HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Plasma Cmax for PF 04965842
研究概览
简要总结
A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) in healthy subjects.
详细描述
A phase 1 study to evaluate the effect of fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor) or fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor) on the pharmacokinetics, safety and tolerability of PF-04965842 in healthy subjects.
This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study drug-drug interaction study. The study includes 2 periods:
In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet. (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842.
In Period 2:
- Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will be evaluated in the first 72 hours post administration of PF 04965842.
- Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole administration. (Treatment C). PK will be evaluated in the first 72 hours post administration of PF 04965842.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Healthy male or female subjects.
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- •Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
- •History of hypersensitivity to or intolerance of fluvoxamine and/or fluconazole.
- •Any condition possibly affecting drug absorption.
- •A positive urine drug test.
- •Screening supine systolic BP <90 mm Hg or 140 mm Hg following at least 5 minutes of supine rest OR Screening supine diastolic BP <50 mm Hg or 90 mm Hg following at least 5 minutes of supine rest.
- •Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
研究组 & 干预措施
PF-04965842
investigational drug
干预措施: Period 1 - Day 1: PF-04965842 administered (Drug)
PF-04965842
investigational drug
干预措施: Period 2: Cohort 1: Fluvoxamine & PF-04965842 (Drug)
PF-04965842
investigational drug
干预措施: Period 2: Cohort 2: Fluconazole & PF-04965842 (Drug)
结局指标
主要结局
Plasma Cmax for PF 04965842
时间窗: First 72 hours post PF-04965842 administration in Period 1 and Period 2
Maximum Observed Plasma Concentration (Cmax) for PF 04965842
AUCinf for PF-04965842
时间窗: First 72 hours post PF-04965842 administration in Period 1 and Period 2
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)
次要结局
- Number of Subjects with clinically significant abnormal Vital Signs(Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2)
- Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance(Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2)
- Number of subjects with Adverse events (AEs)(Screening up to 28 Days after the Last Dose of PF 04965842)
- Number of subjects with laboratory tests findings of potential clinical importance(Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2)