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Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

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ClinicalTrials.gov Identifier: NCT04580797
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 25, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE October 2, 2020
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to Day 10 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A [ Time Frame: Pre-dose and 96 hours post dose ]
  • Number of subjects with clinically relevant changes in vital signs in Part A [ Time Frame: Pre-dose and 96 hours post dose ]
  • Number of participants with clinically relevant changes in clinical laboratory tests in Part A [ Time Frame: Baseline and 96 hours post dose ]
  • Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A [ Time Frame: Baseline to Day 4 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1 [ Time Frame: pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1 ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7 [ Time Frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7 ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7 [ Time Frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 ]
  • Terminal half-life of PF-06700841 in Part B [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations
Official Title  ICMJE A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B
Brief Summary The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition.

Part B is a multiple ascending dose study

Masking: Double (Participant, Investigator)
Masking Description:
Part B is a sponsor open, double blind study where the investigator, medical monitor and the participants will be blinded.
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: PF-06700841 IR
    Immediate release formulation
  • Drug: PF-06700841 MR1
    Modified release formulation 1
  • Drug: PF-06700841 MR2
    Modified release formulation 2
  • Drug: PF-06700841 MR3
    Modified release formulation 3
  • Other: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: PF-06700841: IR, MR1, MR2, MR1_fed
    Participants 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
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841: MR1, MR2, IR, MR1_fed
    Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841: MR2, IR, MR1, MR1_fed
    Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841: IR, MR1, MR2, MR2_fed
    Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841: MR1, MR2, IR, MR2_fed
    Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841: MR2, IR, MR1, MR2_fed
    Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
    Interventions:
    • Drug: PF-06700841 IR
    • Drug: PF-06700841 MR1
    • Drug: PF-06700841 MR2
  • Experimental: PF-06700841 MR3 (Dose A) or matching placebo
    Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
    Interventions:
    • Drug: PF-06700841 MR3
    • Other: Placebo
  • Experimental: PF-06700841 MR3 (Dose B) or matching placebo
    Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
    Interventions:
    • Drug: PF-06700841 MR3
    • Other: Placebo
  • Experimental: PF-06700841 MR3 (Dose C) or matching placebo
    Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition
    Interventions:
    • Drug: PF-06700841 MR3
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 11, 2021
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
  • History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
  • Positive urine drug test.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04580797
Other Study ID Numbers  ICMJE B7931058
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP