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PH-797804 material sparing

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

PH-797804 material sparing · 1 trial · 1 indication

Phase 1 1
NCT01226693A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804Healthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)
predose to day 7 of treatment period
Time for Cmax (Tmax)
predose to day 7 of treatment period
Terminal half-life (t1/2)
predose to day 7 of treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Sequence 3EXPERIMENTAL -
Sequence 4EXPERIMENTAL -
Sequence 5EXPERIMENTALoral, 6mg, single dose
Sequence 6EXPERIMENTALoral, 6mg, single dose

Interventions

NameTypeDescription
PH-797804 material sparing tabletDRUGoral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDRUGoral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDRUGoral, 6mg, single dose
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55. * No evidence of active or latent TB. * An informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence, including abnormal clinical laboratory paramete...

Countries:Singapore
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Frequently asked questions about PH-797804 material sparing

What is PH-797804 used for?

PH-797804 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in clinical development to assess its safety, tolerability, and relative oral bioavailability. The drug is being developed by Pfizer, Inc. (PFE).

Who makes PH-797804?

PH-797804 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule currently in Phase 1 clinical development.

What phase is PH-797804 in?

PH-797804 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study in healthy volunteers has been completed to evaluate its safety, tolerability, and relative oral bioavailability of three formulations.

What clinical trials is PH-797804 in?

PH-797804 has one completed clinical trial, NCT01226693, titled 'A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804'. This Phase 1 study enrolled 18 healthy volunteers in Singapore and was completed.

Is PH-797804 the same as PH-797804 material sparing?

Yes, PH-797804 material sparing refers to the same drug, PH-797804. The term 'material sparing' likely describes a formulation or manufacturing approach used in the clinical trial to reduce the amount of drug substance needed, but the active pharmaceutical ingredient is identical.