Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
- Registration Number
- NCT02070939
- Lead Sponsor
- Pfizer
- Brief Summary
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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAD cohorts 1-7 Experimental Arm PF-06260414 - SAD Cohorts 1-7 Placebo Arm Placebo - MAD cohorts 2-6 Placebo Arm Placebo - Japanese MAD cohort 7 Experimental arm PF-06260414 - Japanese MAD cohort 7 Placebo Arm Placebo - MAD cohorts 2-6 Experimental Arm PF-06260414 -
- Primary Outcome Measures
Name Time Method Changes from baseline in 12-lead ECG parameters 6 weeks Quantitative changes in ECG intervals
Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. 6 weeks Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) 6 weeks Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events 6 weeks Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis 6 weeks 24 hour creatinine clearance (baseline and day 14). Baseline, Day 14 Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG. 6 weeks Changes from baseline in Prostate Specific Antigen (PSA). 6 weeks
- Secondary Outcome Measures
Name Time Method 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 The effects of PF- 06260414 on sex hormones (total testosterone, free testosterone, estradiol, SHBG, LH and FSH) will be evaluated according to the scheduled timepoints in single ascending dose study
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
Trial Locations
- Locations (1)
New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States