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PF-06650833 alone

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: May 20, 2020

PF-06650833 alone development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

PF-06650833 alone clinical trials

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?

PF-06650833 is an investigational small molecule drug developed by Pfizer, Inc. It has been studied in a Phase 1 clinical trial involving healthy adult participants. The trial evaluated PF-06650833 in combination with another drug, PF-06651600, following multiple doses. PF-06650833 has not been approved by the FDA and remains in clinical development.

Who makes PF-06650833?

PF-06650833 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the Phase 1 drug-drug interaction study of PF-06650833 conducted in the United States.

What phase is PF-06650833 in?

PF-06650833 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-06650833 in?

PF-06650833 has been studied in 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 adult volunteers in the United States and was an uncontrolled study.

What is PF-06650833 used for?

PF-06650833 is an investigational drug that has been studied in healthy adult volunteers in a Phase 1 drug-drug interaction trial. No approved therapeutic indication has been established for PF-06650833, and it remains in clinical development.