A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF CARBAMAZEPINE ON PF-07248144 PHARMACOKINETICS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) Period 1
研究概览
简要总结
The purpose of the study is to learn how the study medicine called carbamazepine changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with carbamazepine.
Carbamazepine can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 8 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with carbamazepine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-07248144 with and without Carbamazepine
PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14.
Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2
干预措施: PF-07248144 (Drug)
PF-07248144 with and without Carbamazepine
PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14.
Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) Period 1
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
Cmax Period 2
时间窗: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Period 1
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
AUCinf Period 2
时间窗: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast). Period 1. To be used as the primary endpoint if AUCinf cannot be reliably estimated
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
AUClast. Period 2. To be used as the primary endpoint if AUCinf cannot be reliably estimated
时间窗: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
次要结局
- Number of Treatment-Emergent Treatment-Related AEs by Severity(From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days))
- Number of Participants With Laboratory Test Abnormalities(From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days))
- Number of Participants With Clinically Significant Physical Examination Abnormalities(From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days))
- Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria(From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days))
- Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters(From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days))