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PF-06273340

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 4, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

PF-06273340 · 3 trials · 1 indication

Phase 1 3
NCT02260947Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain EndpointsHealthy
COMPLETED20 Analytics
NCT01934738A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)Healthy
COMPLETED52 Analytics
NCT01706796A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed StateHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints
Healthy
NCT0226094720
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PHASE1COMPLETED
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
Healthy
NCT0193473852
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PHASE1COMPLETED
A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed State
Healthy
NCT0170679612
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Study Endpoints

Primary Endpoints

Thermal pain detection threshold
0.5 - 4 hours
Ultra-violet light sensitized pain detection threshold
0.5 - 4 hours
Pressure pain tolerance threshold
0.5 - 4 hours
Electrical pain tolerance threshold
0.5 - 4 hours
Cold pressor tolerance threshold
0.5 - 4 hours
Maximum Observed Plasma Concentration (Cmax)
14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
14 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
up to 48 h post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
up to 48 h post dose
Elimination half life
up to 48 h post dose

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
0.5 - 10 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0.5 - 10 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0.5 - 10 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
4ACTIVE_COMPARATOR -
5PLACEBO_COMPARATOR -
Group 1: Cohort 1EXPERIMENTAL -
Group 1: Cohort 2EXPERIMENTAL -
Group 1: Cohort 3EXPERIMENTAL -
Group 2: Cohort 4EXPERIMENTAL -
Group 1: Cohort 5EXPERIMENTAL -
Group 2: Cohort 6EXPERIMENTAL -
PF-06273340 Oral Solution FastedEXPERIMENTAL -
PF-06273340 Immediate Release Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR1) Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR2) Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR1) Tablet FedEXPERIMENTAL -
PF-06273340 Modified Release (MR2) Tablet FedEXPERIMENTAL -

Interventions

NameTypeDescription
PF-06273340DRUGPF-06273340 50 mg
PregabalinDRUGPregabalin 300 mg
IbuprofenDRUGIbuprofen 600 mg
PlaceboDRUGMatching Placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 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 or clinical la...

Countries:NetherlandsBelgiumSingapore
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Frequently asked questions about PF-06273340

What is PF-06273340 used for?

PF-06273340 is an investigational small molecule being studied in healthy volunteers. It has been evaluated in Phase 1 clinical trials to assess its safety, toleration, and plasma concentration, as well as its analgesic effects using evoked pain endpoints. It is not approved for any indication and remains in clinical development.

Who makes PF-06273340?

PF-06273340 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored multiple Phase 1 clinical trials of this investigational small molecule in healthy subjects.

What phase is PF-06273340 in?

PF-06273340 is in Phase 1 clinical development. All three completed trials are Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. Its development status is limited to early-stage clinical testing.

What clinical trials is PF-06273340 in?

PF-06273340 has been studied in three completed Phase 1 trials. NCT01706796 compared immediate release and modified release tablet formulations to an oral solution in fasted and fed states. NCT01934738 evaluated multiple oral doses in two age groups. NCT02260947 assessed analgesic effects using evoked pain endpoints in healthy male volunteers.

Is PF-06273340 the same as any other drug?

PF-06273340 is the primary name used for this investigational small molecule in clinical trial records. No alternative names have been associated with this drug in the available clinical trial information. It is identified solely by its PF-06273340 designation in the studies conducted by Pfizer.