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

NCT04580797

Last updated date
Study Location
Quotient Sciences Screening Office
Coral Gables, Florida, 33134, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 8, 2021
Estimated Primary Completion Date January 8, 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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020

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