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PF-04878691

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Pfizer, Inc.|Last 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

Clinical trial landscape

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 used for?

PF-04878691 is an investigational small molecule being developed for the treatment of Hepatitis C Virus (HCV). It is intended for use in infectious disease settings, targeting the viral infection. The drug is currently in clinical development, with studies evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in affected populations.

Who makes PF-04878691?

PF-04878691 is being developed by Pfizer, Inc., a multinational pharmaceutical company headquartered in the United States. Pfizer trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Hepatitis C Virus.

What phase is PF-04878691 in?

PF-04878691 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for its safety and pharmacological profile in the context of Hepatitis C Virus.

What clinical trials is PF-04878691 in?

PF-04878691 has one completed clinical trial registered under NCT00810758. This Phase 1 study, titled "Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691," enrolled 24 participants in the United States. The trial was randomized and double-blind, though it did not use a control group.

Is PF-04878691 FDA approved?

PF-04878691 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial evaluated its safety and pharmacological properties in healthy volunteers, but the drug has not yet progressed through the later stages of clinical testing required for regulatory approval.