A Phase 1 Open-Label Fixed-Sequence Two-Period Crossover Study Of The Effect Of Multiple Doses Of Tamoxifen On PD-0332991 Pharmacokinetics In Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991
研究概览
简要总结
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male between the ages of 18 and 55 years of age inclusive
- •Body mass index (BMI) between 17.5 and 30.5 kg/m2
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •a positive urine drug screen
- •a supine systolic blood pressure >140 mm Hg, or diastolic blood pressure >90 mm H.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
研究组 & 干预措施
Two-Period Fixed-Sequence Arm
This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991.
干预措施: PD-0332991 alone (Drug)
Two-Period Fixed-Sequence Arm
This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991.
干预措施: Tamoxifen 60 mg (Drug)
Two-Period Fixed-Sequence Arm
This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991.
干预措施: Tamoxifen 20 mg (Drug)
Two-Period Fixed-Sequence Arm
This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991.
干预措施: PD-0332991 combination (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991
时间窗: 0-144 hrs post PD-0332991 dose
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
次要结局
- Plasma Decay Half-Life (t1/2) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Apparent Oral Clearance (CL/F) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen(Days 1, 5, 12, 21, 22, and 28 of Period 2)
- Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen(Days 1, 5, 12, 21, 22, and 28 of Period 2)
- Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen(Days 1, 5, 12, 21, 22, and 28 of Period 2)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Maximum Observed Plasma Concentration (Cmax) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Apparent Volume of Distribution (Vz/F) of PD-0332991(0-144 hrs post PD-0332991 dose)
- Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen(Days 1, 5, 12, 21, 22, and 28 of Period 2)