A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06260414 In Healthy Western And Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes from baseline in 12-lead ECG parameters
研究概览
简要总结
This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male between the ages of 21 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Additional inclusion criteria for subjects to be enrolled in Japanese cohort only: Japanese subjects who have four Japanese grandparents born in Japan.
排除标准
- •Serum total testosterone level <270 or >1070 ng/dL
- •Serum Prostate Specific Antigen (PSA) level >4 ng/mL.
- •Hematocrit >48%.
- •eGFR >150 ml/min/1.73m2.
研究组 & 干预措施
SAD cohorts 1-7 Experimental Arm
干预措施: PF-06260414 (Drug)
SAD Cohorts 1-7 Placebo Arm
干预措施: Placebo (Drug)
MAD cohorts 2-6 Experimental Arm
干预措施: PF-06260414 (Drug)
MAD cohorts 2-6 Placebo Arm
干预措施: Placebo (Drug)
Japanese MAD cohort 7 Experimental arm
干预措施: PF-06260414 (Drug)
Japanese MAD cohort 7 Placebo Arm
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in 12-lead ECG parameters
时间窗: 6 weeks
Quantitative changes in ECG intervals
Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
时间窗: 6 weeks
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)
时间窗: 6 weeks
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
时间窗: 6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis
时间窗: 6 weeks
24 hour creatinine clearance (baseline and day 14).
时间窗: Baseline, Day 14
Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.
时间窗: 6 weeks
Changes from baseline in Prostate Specific Antigen (PSA).
时间窗: 6 weeks
次要结局
- Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.(6 weeks)
- Single Dose: AUC(hormone or PSA), C0(hormone or PSA), Maximum PCB, Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).(6 weeks)
- Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.(6 weeks)
- Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).(6 weeks)
- Multiple Dose: AUC(hormone or PSA), C0(hormone or PSA), Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).(6 weeks)