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PF-06700841 IR

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 8, 2021

PF-06700841 IR development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

PF-06700841 IR clinical trials

PF-06700841 IR · 1 trial · 1 indication

Phase 1 1
NCT04580797Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release FormulationsHealthy Participants
COMPLETED36 Analytics
PHASE1COMPLETED
Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
Baseline to Day 10

Secondary Endpoints

Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A
Pre-dose and 96 hours post dose
Number of subjects with clinically relevant changes in vital signs in Part A
Pre-dose and 96 hours post dose
Number of participants with clinically relevant changes in clinical laboratory tests in Part A
Baseline and 96 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
PF-06700841: IR, MR1, MR2, MR1_fedEXPERIMENTALParticipants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR1_fedEXPERIMENTALParticipants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR1_fedEXPERIMENTALParticipants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: IR, MR1, MR2, MR2_fedEXPERIMENTALParticipants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR2_fedEXPERIMENTALParticipants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR2_fedEXPERIMENTALParticipants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841 MR3 (Dose A) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose B) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose C) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition

Interventions

NameTypeDescription
PF-06700841 IRDRUGImmediate release formulation
PF-06700841 MR1DRUGModified release formulation 1
PF-06700841 MR2DRUGModified release formulation 2
PF-06700841 MR3DRUGModified release formulation 3
PlaceboOTHERMatching placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male and female participants between 18 -55 years of age. * BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Participants who are willing and able to comply with all scheduled visits, treatment * plan, laboratory tests, lifestyle considerations, a...

Countries:United States
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Frequently asked questions about PF-06700841 IR

What is PF-06700841 IR?

PF-06700841 IR is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). The IR designation refers to an immediate-release formulation. It has been studied in a Phase 1 clinical trial in healthy participants, and its therapeutic indications have not been disclosed.

Who is developing PF-06700841 IR?

PF-06700841 IR is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 clinical trial of this asset.

What phase is PF-06700841 IR in?

PF-06700841 IR is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-06700841 IR in?

PF-06700841 IR has been evaluated in one completed Phase 1 trial, NCT04580797, titled "Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations." The trial enrolled 36 healthy participants in the United States.

What was the design of the PF-06700841 IR Phase 1 trial?

The Phase 1 trial NCT04580797 was a randomized, double-blind, controlled study of PF-06700841 IR in 36 healthy volunteers aged 18 years and older. It assessed pharmacokinetics and safety after single and multiple oral doses of modified-release formulations. The trial has been completed.