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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD cohorts 1-7 Experimental Arm | Experimental |
| |
| SAD Cohorts 1-7 Placebo Arm | Placebo Comparator |
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| MAD cohorts 2-6 Experimental Arm | Experimental |
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| MAD cohorts 2-6 Placebo Arm | Placebo Comparator |
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| Japanese MAD cohort 7 Experimental arm | Experimental |
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| Japanese MAD cohort 7 Placebo Arm | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06260414 | Drug | Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) | 6 weeks | |
| Changes from baseline in 12-lead ECG parameters | Quantitative changes in ECG intervals | 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 in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27085586 | Derived | Bhattacharya I, Tarabar S, Liang Y, Pradhan V, Owens J, Oemar B. Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects. Clin Ther. 2016 Jun;38(6):1401-1416. doi: 10.1016/j.clinthera.2016.03.025. Epub 2016 Apr 13. |
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| Placebo | Drug | Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format |
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| PF-06260414 | Drug | Subjects will receive PF-06260414 doses (solution) twice daily for 14 days |
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| Placebo | Drug | Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days |
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| PF-06260414 | Drug | Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days |
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| Placebo | Drug | Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days |
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| 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). | 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 | 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 |
| ID | Term |
|---|---|
| C000622589 | PF-06260414 |
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