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PF-04776548

Phase 1

Human Immunodeficiency Virus (HIV) | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 2, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

PF-04776548 · 1 trial · 1 indication

Phase 1 1
NCT01045317A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The BodyHuman Immunodeficiency Virus (HIV)
COMPLETED10 Analytics
PHASE1COMPLETED
A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The Body
Human Immunodeficiency Virus (HIV)
NCT0104531710
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Study Endpoints

Primary Endpoints

Pharmacokinetics: For IV dosing: Cmax, Tmax, AUClast, AUCinf, t½, CL, Vss. For oral dosing: Cmax, Tmax, Tlag, AUClast, AUCinf, t½, CL/F, Vz/F, F.
14 days

Secondary Endpoints

Safety and toleration: adverse events will also be reported.
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
intravenous or oral administrationEXPERIMENTAL -

Interventions

NameTypeDescription
PF-04776548DRUGsingle intravenous or oral administration of 0.1mg PF-04776548.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 65 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 l...

Countries:United Kingdom
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Frequently asked questions about PF-04776548

What is PF-04776548 used for?

PF-04776548 is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV). It is in Phase 1 clinical development and is not yet approved for any use.

Who makes PF-04776548?

PF-04776548 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-04776548 in?

PF-04776548 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of HIV.

What clinical trials is PF-04776548 in?

PF-04776548 has one completed Phase 1 clinical trial, identified as NCT01045317. This study investigated the clearance of the compound from the body following a very low micro dose, using a radiotracer to quantify expected low concentrations.

Is PF-04776548 being studied in healthy volunteers?

Yes, the completed Phase 1 trial of PF-04776548 enrolled healthy volunteers. The study, NCT01045317, included 10 participants aged 18 years and older and was conducted in the United Kingdom.