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PF-04629991

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: May 5, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

PF-04629991 · 1 trial · 1 indication

Phase 1 1
NCT00797342A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy VolunteersHealthy Volunteers
COMPLETED27 Analytics
PHASE1COMPLETED
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
2 weeks
Safety/Tolerability e.g., reported adverse events and safety laboratory studies
2 weeks
Pharmacodynamics e.g., changes in a peripheral blood biomarker
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
first of three dosing cohortsOTHER -
second of three dosing cohortsOTHER -
third of three dosing cohortsOTHER -

Interventions

NameTypeDescription
PF-04629991DRUGOral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy non-smoking men and women * body mass index 18-30 kg/m2 Exclusion Criteria: * Women must not be able to have children * no current infections

Countries:Belgium
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Frequently asked questions about PF-04629991

What is PF-04629991 used for?

PF-04629991 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The drug is being evaluated for safety, tolerability, pharmacokinetics and pharmacodynamics in a clinical trial setting.

Who makes PF-04629991?

PF-04629991 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational small molecule drug.

What phase is PF-04629991 in?

PF-04629991 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety, tolerability, pharmacokinetics and pharmacodynamics.

What clinical trials is PF-04629991 in?

PF-04629991 has one completed Phase 1 clinical trial, identified as NCT00797342. This study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in 27 healthy volunteers in Belgium. The trial was randomized, double-blind and controlled.

Is PF-04629991 the same as any other drug?

PF-04629991 is a unique investigational compound developed by Pfizer. No alternative names for this drug have been reported in clinical trial registries. It is identified solely by its Pfizer code name PF-04629991 in the completed Phase 1 study.