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PF-04620110

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 6, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

PF-04620110 · 6 trials · 5 indications

Phase 1 6
NCT01298518A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes PatientsType 2 Diabetes Patients
COMPLETED48 Analytics
NCT01166217A Single Dose Study Of PF-04620110 In Healthy SubjectsHealthy
COMPLETED12 Analytics
NCT01146327A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese SubjectsHealthy
COMPLETED60 Analytics
NCT01064492A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult SubjectsHealthy Volunteers
COMPLETED12 Analytics
NCT00959426A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy VolunteersObesity
COMPLETED71 Analytics
NCT00799006A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy VolunteersOverweight
COMPLETED27 Analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Type 2 Diabetes PatientsUnlock trial analytics
PHASE1COMPLETED
A Single Dose Study Of PF-04620110 In Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
ObesityUnlock trial analytics
PHASE1COMPLETED
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
following each treatment
To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
Day 1 to Day 13
To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.
Day 6 and Day 14
Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.
following each treatment
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
Baseline to 2 weeks
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
4 days/dose group
The single dose pharmacokinetics of PF-04620110 will be assessed
4 days/dose group

Secondary Endpoints

Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04620110EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
ABCE, ACBD, BACD, BCAE, CABE and CBADEXPERIMENTAL -
Placebo ComparatorPLACEBO_COMPARATOR -
ABC, ACB, BAC, BCA, CAB, and CBAEXPERIMENTAL -

Interventions

NameTypeDescription
PF-04620110DRUG5 mg of PF-04620110 given once daily
PlaceboDRUGMatching placebo giving for 4 weeks
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male and/or female subjects between the ages of 18 and 60 years; * Body Mass Index (BMI) of \>25.0 kg/m2 and \<40 kg/m2; * Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines; * Subjects who have been on well-tolerated and stable doses of me...

Countries:United StatesSingaporeBelgium
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Frequently asked questions about PF-04620110

What is PF-04620110?

PF-04620110 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It has been studied in Phase 1 clinical trials for conditions including obesity, overweight, healthy volunteers, and type 2 diabetes patients. It is not approved and remains in clinical development.

What is PF-04620110 used for?

PF-04620110 has been investigated for use in obesity, overweight, and type 2 diabetes patients, as well as in healthy volunteers. It was studied in early-stage clinical trials to assess its safety, tolerability, and pharmacokinetics in these populations.

Who makes PF-04620110?

PF-04620110 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored Phase 1 clinical trials of this investigational small molecule.

What phase is PF-04620110 in?

PF-04620110 is in Phase 1 clinical development. All completed trials for this drug are Phase 1 studies. It is an investigational agent and has not received FDA approval for any indication.

What clinical trials is PF-04620110 in?

PF-04620110 has been studied in four completed Phase 1 trials: NCT00959426 in overweight and obese healthy volunteers, NCT01064492 in healthy adults for bioavailability and food effect, NCT01166217 in healthy subjects, and NCT01298518 in type 2 diabetes patients. All trials are completed.

Is PF-04620110 the same as any other drug?

PF-04620110 is the primary identifier for this investigational compound. No alternative names have been reported in the clinical trial data. It is a small molecule developed by Pfizer, Inc. for potential metabolic indications.