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PF-04449913, ketoconazole

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 10, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

PF-04449913, ketoconazole · 1 trial · 1 indication

Phase 1 1
NCT01749085Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug LevelsHealthy Volunteers
COMPLETED14 Analytics
PHASE1COMPLETED
Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug Levels
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
8 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
8 days

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
8 days
Apparent Oral Clearance (CL/F)
8 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
8 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -

Interventions

NameTypeDescription
PF-04449913, ketoconazoleDRUGSubjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and 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 and...

Countries:United States
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Frequently asked questions about PF-04449913, ketoconazole

What is PF-04449913 used for?

PF-04449913 is an investigational small molecule being studied for use in acute myeloid leukemia, myelodysplastic syndrome, and other hematologic malignancies. It has also been evaluated in healthy volunteers to understand how the body processes the drug. The drug is in clinical development and is not approved for any indication.

Who makes PF-04449913?

PF-04449913 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored multiple clinical trials of the drug in patients with blood cancers and healthy volunteers.

What phase is PF-04449913 in?

PF-04449913 has completed Phase 2 clinical trials. It is an investigational drug and remains in clinical development, meaning it has not been approved by regulatory authorities. All trials listed for the drug have been completed, with no active trials currently ongoing.

What clinical trials is PF-04449913 in?

PF-04449913 has been studied in several completed trials. NCT01546038 was a Phase 2 study combining the drug with chemotherapy in acute myeloid leukemia or myelodysplastic syndrome. NCT02038777 was a Phase 1 study in Japanese patients with hematologic malignancies. NCT02110342 was a Phase 1 healthy volunteer study, and NCT02367456 was a Phase 1 combination study with azacitidine.

Is PF-04449913 the same as glasdegib?

PF-04449913 is also known as glasdegib. In one clinical trial, NCT02367456, the drug is referred to as PF-04449913 (Glasdegib), confirming that both names refer to the same investigational compound being developed by Pfizer.