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PF-06260414

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Nov 14, 2018

PF-06260414 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

PF-06260414 clinical trials

PF-06260414 · 1 trial · 1 indication

Phase 1 1
NCT02070939Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male SubjectsHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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

Secondary Endpoints

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
Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAD cohorts 1-7 Experimental ArmEXPERIMENTAL -
SAD Cohorts 1-7 Placebo ArmPLACEBO_COMPARATOR -
MAD cohorts 2-6 Experimental ArmEXPERIMENTAL -
MAD cohorts 2-6 Placebo ArmPLACEBO_COMPARATOR -
Japanese MAD cohort 7 Experimental armEXPERIMENTAL -
Japanese MAD cohort 7 Placebo ArmPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-06260414DRUGSubjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format
PlaceboDRUGSubjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
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Eligibility Criteria

Age Range21 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about PF-06260414

What is PF-06260414?

PF-06260414 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult male volunteers rather than in patients with a specific disease. The compound remains in early clinical development.

Who makes PF-06260414?

PF-06260414 is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in the United States.

What phase is PF-06260414 in?

PF-06260414 is in Phase 1 clinical development. Its only recorded trial, NCT02070939, was a Phase 1 study that has been completed. The compound is investigational and has not been approved by the FDA for any use.

What clinical trials is PF-06260414 in?

PF-06260414 has been evaluated in one clinical trial, NCT02070939, titled a study to evaluate safety and tolerability of single and multiple ascending doses of PF-06260414 in healthy Western and Japanese male subjects. The Phase 1 trial enrolled 72 participants, was placebo controlled and double blind, and is completed.

How was the PF-06260414 Phase 1 trial designed?

The Phase 1 trial of PF-06260414, NCT02070939, was a randomized, double-blind, placebo-controlled study of single and multiple ascending doses. It enrolled 72 healthy male volunteers aged 21 years and older in the United States, including Western and Japanese subjects, and it has been completed.