Healthy
Conditions
Keywords
Phase 1, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Dose Escalation, Safety Tolerability, PK, PD, PF-06460414
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 .
Interventions
DRUGPF-06260414
Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format
DRUGPlacebo
Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. | 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 | — |
| Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) | 6 weeks | — |
| Changes from baseline in 12-lead ECG parameters | 6 weeks | Quantitative changes in ECG intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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: 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 | — |
| Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½. | 6 weeks | — |
Countries
United States
Outcome results
None listed