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PF-06260414

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 14, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains under investigation for its safety and tolerability.

What is PF-06260414 used for?

PF-06260414 is being studied for use in healthy volunteers, specifically to evaluate its safety and tolerability. It is an investigational small molecule in Phase 1 clinical development, with no approved indication at this time.

Who makes PF-06260414?

PF-06260414 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-06260414 in?

PF-06260414 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers to assess its safety and tolerability.

What clinical trials is PF-06260414 in?

PF-06260414 has one completed Phase 1 trial, NCT02070939, which evaluated single and multiple ascending doses in healthy Western and Japanese male subjects. The trial enrolled 72 participants in the United States and was placebo-controlled and double-blind.

Is PF-06260414 FDA approved?

PF-06260414 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development, with one completed trial in healthy volunteers. It remains under study and has not been approved for any use.