A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AUCinf of midazolam following a single oral dose
研究概览
简要总结
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.
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
- 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
- •Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
- •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 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).
- •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
- •Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
- •History of hypersensitivity to midazolam or any other benzodiazepine
研究组 & 干预措施
Sequence 1
midazolam alone followed by combination of PF 06835919 and midazolam
干预措施: PF 06835919 (Drug)
Sequence 1
midazolam alone followed by combination of PF 06835919 and midazolam
干预措施: Midazolam (Drug)
Sequence 2
PF 06835919 in combination with midazolam followed by midazolam alone
干预措施: PF 06835919 (Drug)
Sequence 2
PF 06835919 in combination with midazolam followed by midazolam alone
干预措施: Midazolam (Drug)
结局指标
主要结局
AUCinf of midazolam following a single oral dose
时间窗: Baseline up to 51 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
次要结局
- AUClast of midazolam following a single oral dose.(Baseline up to 51 days)
- Cmax of midazolam following a single oral dose.(Baseline up to 51 days)
- Incidence of Adverse Events in participants(Screening up to 79 days)