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1 mg, 5 mg, 10 mg

Phase 1

Healthy | Unknown | Other |Pfizer, Inc.|Last Updated: Feb 15, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

1 mg, 5 mg, 10 mg · 1 trial · 1 indication

Phase 1 1
NCT01217918Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult SubjectsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
Healthy
NCT0121791830
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Study Endpoints

Primary Endpoints

Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
Days 1 and 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALPH-797804
Cohort 2EXPERIMENTALPH-797804
Cohotr 3EXPERIMENTALPH-797804

Interventions

NameTypeDescription
1 mgDRUG1 mg or placebo a material sparing tablet per day for 10 days
5 mgDRUG5 mg or placebo as material sparing tablet per day for 10 days
10 mgDRUG10 mg or placebo as a material sparing tablet per day for 10 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy Volunteers * Japanese Exclusion Criteria: * Subjects with clinically significant skin lesions * Subjects with known tuberculosis infection

Countries:United States
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Frequently asked questions about 1 mg, 5 mg, 10 mg

What is 1 mg, 5 mg, 10 mg used for?

1 mg, 5 mg, 10 mg is an investigational drug being studied for use in meningococcal vaccine, non-Hodgkin lymphoma, growth disorder, acute otitis media, hypogonadism, and healthy volunteers. It is currently in Phase 1 clinical development.

Who makes 1 mg, 5 mg, 10 mg?

1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical development.

What phase is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791, NCT00039910, NCT00174421, and NCT01163851. These trials have investigated its use in conditions such as thrombocytopenia, non-Hodgkin lymphoma, growth disorder, and hypercholesterolemia.

Is 1 mg, 5 mg, 10 mg the same as PN-152,243?

1 mg, 5 mg, 10 mg is also known as PN-152,243 and PN-196,444 in clinical trials. These names refer to the same investigational drug being developed by Pfizer.