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PF-06650833 alone

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 20, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

PF-06650833 alone · 1 trial · 1 indication

Phase 1 1
NCT03827668A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTSHealthy
COMPLETED15 Analytics
PHASE1COMPLETED
A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

PF-06650833 Cmax
Fold-change from Period 1/Day 5 to Period 2/Day 12

Maximum observed concentration (Cmax) derived from plasma

PF-06650833 AUCtau
Fold-change from Period 1/Day 5 to Period 2/Day 12

Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.

PF-06651600 Cmax
Fold-change from Period 2/Day 7 to Period 2/Day 12

Maximum observed concentration (Cmax) derived from plasma

PF-06651600 AUCtau
Fold-change from Period 2/Day 7 to Period 2/Day 12

Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.

Secondary Endpoints

Percentage of participants with treatment emergent adverse events
From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
Percentage of participants with clinical laboratory test results above/below certain threshold
At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
Percentage of participants with vital signs above/below certain threshold
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Single armEXPERIMENTALThe study will have only one study group in a fixed-sequence type of design with two periods

Interventions

NameTypeDescription
PF-06650833 aloneDRUGIn Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
PF-06651600 aloneDRUGIn Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
PF-06650833 together with PF-06651600DRUGIn Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD) * Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood...

Countries:United States
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Frequently asked questions about PF-06650833 alone

What is PF-06650833 used for?

PF-06650833 is an investigational small molecule being studied in healthy participants. It is not approved for any disease and is in clinical development to assess its safety and interactions. The only completed trial evaluated it in healthy volunteers in the United States.

Who makes PF-06650833?

PF-06650833 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 1 clinical trial of this investigational drug.

What phase is PF-06650833 in?

PF-06650833 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is no longer in active clinical testing.

What clinical trials is PF-06650833 in?

PF-06650833 has one completed Phase 1 trial, NCT03827668, titled "A Drug-Drug Interaction Study Between PF-06650833 and PF-06651600 Following Multiple Doses in Healthy Participants." The trial enrolled 15 healthy adults in the United States and was not randomized or blinded.

Is PF-06650833 the same as PF-06651600?

No, PF-06650833 and PF-06651600 are different investigational drugs. They were studied together in a drug-drug interaction trial, NCT03827668, to evaluate how they affect each other when given in multiple doses to healthy participants.