Recent Updates
Recently added Catalysts

PF-03882845

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jul 6, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PF-03882845 · 2 trials · 2 indications

Phase 1 2
NCT01314898A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy VolunteersHealthy Volunteers
COMPLETED12 Analytics
NCT01366287A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its AbsorptionDiabetes Mellitus, Type 2
COMPLETED12 Analytics
PHASE1COMPLETED
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Twenty-four hour urinary Na/K ratio (AUC(0-24)).
0-24hr postdose per period
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
predose and post each dose (24, 48 and 96 hour timepoints)

Post dose is measured at 24, 48 and 96 hours after dose.

Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
45 days

Secondary Endpoints

Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
0-24 hr post dose per period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTAL -
Suspension/fastedEXPERIMENTAL -
Tablet/fastedEXPERIMENTAL -
Tablet/fedEXPERIMENTAL -

Interventions

NameTypeDescription
3 mg PF-03882845DRUG3 mg PF-03882845, single oral dose
10 mg PF-03882845DRUG10 mg PF-03882845, single oral dose
30 mg PF-03882845DRUG30 mg PF-03882845, single oral dose
100 mg PF-03882845DRUG100 mg PF-03882845, single oral dose
SpironolactoneDRUG100 mg spironolactone, single oral dose
PF-03882845DRUG25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment pl...

Countries:United StatesBelgium
Unlock Eligibility Criteria

Frequently asked questions about PF-03882845

What is PF-03882845 used for?

PF-03882845 is an investigational small molecule being studied for use in healthy volunteers and in patients with type 2 diabetes mellitus. It is in Phase 1 clinical development for these metabolic conditions.

Who is developing PF-03882845?

PF-03882845 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-03882845 in?

PF-03882845 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is PF-03882845 in?

PF-03882845 has been studied in two completed Phase 1 clinical trials. One trial (NCT01314898) evaluated its antimineralocorticoid activity in healthy volunteers in the United States. Another trial (NCT01366287) studied its absorption from tablet versus suspension formulations and the effect of food in healthy volunteers with type 2 diabetes in Belgium.

Is PF-03882845 the same as any other drug?

PF-03882845 is the only name provided for this investigational drug. It is not known by any other names.