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PF-04937319/ ketoconazole

Phase 1

Human Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 16, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

PF-04937319/ ketoconazole · 1 trial · 1 indication

Phase 1 1
NCT01468714A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy SubjectsHuman Volunteers
COMPLETED10 Analytics
PHASE1COMPLETED
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
Human VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of PF-04937319
Day 1 & Day 6
Tmax of PF-04937319
Day 1 & Day 6
AUClast of PF-04937319
Day 1 & Day 6
(as data permits) AUCinf of PF-04937319
Day 1 & Day 6
(as data permits) t1/2 of PF-04937319
Day 1 & Day 6
Cmax of PF-04937319 M1 metabolite
Day 1 & Day 6
Tmax of PF-04937319 M1 metabolite
Day 1 & Day 6
AUClast of PF-04937319 M1 metabolite
Day 1 & Day 6
(as data permits) AUCinf of PF-04937319 M1 metabolite
Day 1 & Day 6
(as data permits) t1/2 of PF-04937319 M1 metabolite
Day 1 & Day 6

Secondary Endpoints

Urinary recovery of PF-04937319 M1 metabolite
Day 1
(as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite
Day 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Interventions

NameTypeDescription
PF-04937319 / ketoconazoleDRUGSingle 20 mg dose of PF-04937319 on day 1, multiple dose of ketoconazole 200 mg twice daily from day 3 to 7, single 20 mg dose of PF-04937319 on day 6
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female 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 ...

Countries:United States
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Frequently asked questions about PF-04937319/ ketoconazole

What is PF-04937319 used for?

PF-04937319 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It has been evaluated in clinical trials involving patients with Type 2 Diabetes and in healthy subjects. The drug is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development.

Who makes PF-04937319?

PF-04937319 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 2 clinical development for the treatment of Type 2 Diabetes Mellitus.

What phase is PF-04937319 in?

PF-04937319 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed Phase 1 and Phase 2 trials, including a Phase 2 study comparing it to glimepiride in patients with Type 2 Diabetes on metformin.

What clinical trials has PF-04937319 been in?

PF-04937319 has been studied in four completed clinical trials. These include NCT01044537 and NCT01272804, which assessed safety, tolerability, and pharmacokinetics in patients with Type 2 Diabetes. NCT01513928 evaluated different formulations in healthy subjects in Singapore, and NCT01517373 was a Phase 2 efficacy and safety study comparing PF-04937319 to glimepiride in patients with Type 2 Diabetes on metformin.

Is PF-04937319 being studied in patients with Type 2 Diabetes?

Yes, PF-04937319 has been studied in patients with Type 2 Diabetes Mellitus. Clinical trials have enrolled patients with this condition, including a Phase 2 study with 304 participants that compared the drug to glimepiride in patients also taking metformin. The trials were conducted in multiple countries, including the United States, Bulgaria, Canada, Hungary, India, Slovakia, and Taiwan.