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PF-06700841 IR

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 8, 2021

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

Clinical trial landscape

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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied to evaluate its pharmacokinetics and safety after single and multiple oral doses as modified release formulations.

What does PF-06700841 IR target?

The molecular target of PF-06700841 IR has not been disclosed in available clinical trial information. The drug is a small molecule being studied in healthy participants to assess its pharmacokinetics and safety profile.

Who makes PF-06700841 IR?

PF-06700841 IR is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and safety in healthy participants.

What phase is PF-06700841 IR in?

PF-06700841 IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which studied the drug in healthy participants.

What clinical trials is PF-06700841 IR in?

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

Is PF-06700841 IR the same as PF-06700841?

PF-06700841 IR is a modified release formulation of the investigational drug PF-06700841. The "IR" designation indicates an immediate release version, which is being studied to evaluate its pharmacokinetics and safety in healthy participants.