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PF-04878691

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Dec 1, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

PF-04878691 clinical trials

PF-04878691 · 1 trial · 1 indication

Phase 1 1
NCT00810758Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691Hepatitis C Virus
COMPLETED24 Analytics
PHASE1COMPLETED
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Hepatitis C VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and toleration of multiple ascending oral doses of PF-04878691
3 weeks

Secondary Endpoints

To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04878691EXPERIMENTAL -

Interventions

NameTypeDescription
PF-04878691 3mgDRUGOral solution, 3mg, twice weekly, 2 weeks
PF-04878691 6mgDRUGOral solution, 6mg, twice weekly, 2 weeks
PF-04878691 9mgDRUGOral solution, 9mg, twice weekly, 2 weeks
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18-55, inclusive. * Body Mass Index (BMI) of 18-30 kg/m2; total body weight \>50kg (110lbs). Exclusion Criteria: * Pregnant or nursing females. * Females of child-bearing potential. * Evidence of history of clinically s...

Countries:United States
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Frequently asked questions about PF-04878691

What is PF-04878691?

PF-04878691 is an investigational small molecule antiviral developed by Pfizer, Inc. for hepatitis C virus infection. It is a Phase 1 candidate that has been studied in a single completed clinical trial. It is not an approved medicine and remains in early clinical development.

What is PF-04878691 used for?

PF-04878691 was studied for the treatment of hepatitis C virus infection, an infectious disease of the liver. The only recorded trial enrolled healthy adult volunteers rather than patients with chronic hepatitis C, so the program was evaluated in an early-stage setting. It is not approved for any use.

Who makes PF-04878691?

PF-04878691 is 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. No partner or licensing arrangement for this asset is part of the public record for the program.

What phase is PF-04878691 in?

PF-04878691 is in Phase 1 development. Its single clinical trial, NCT00810758, has been completed, and no active trials of the compound are ongoing. Because it has only completed early Phase 1 testing, PF-04878691 is investigational and has not received FDA approval for hepatitis C virus infection.

What clinical trials is PF-04878691 in?

PF-04878691 has been studied in one clinical trial, NCT00810758, titled a multiple oral dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04878691. The Phase 1 trial enrolled 24 healthy volunteers in the United States, used a randomized, double-blind design, and has completed.