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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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

- Female participants of non-childbearing potential and male participants who are
overtly healthy as determined by medical evaluation including medical history,
physical examination, clinical laboratory tests, and cardiac monitoring.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Capable of giving signed informed consent.

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.

- Any condition possibly affecting drug absorption.

- History of human immunodeficiency virus infection (HIV), hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or
hepatitis C antibody.

- Participants with benign ethnic neutropenia or cyclic neutropenia.

- Other acute or chronic medical or psychiatric condition.

- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.

- Previous administration with an investigational drug within 30 days or 5 half-lives
preceding the first dose of investigational product used in this study (whichever is
longer).

- A positive urine drug test.

- Screening supine blood pressure (BP) ?140 mmHg (systolic) or ?90 mmHg (diastolic),
following at least 5 minutes of supine rest.

- Baseline 12-lead standard electrocardiogram (ECG) that demonstrates clinically
relevant abnormalities.

- Participants with ANY of the following abnormalities in clinical laboratory tests at
screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level
?1.25× upper limit of normal (ULN); total bilirubin level ?1.5× ULN; participants with
a history of Gilbert's syndrome may have direct bilirubin measured and would be
eligible for this study provided the direct bilirubin level is ?ULN; hemoglobin ?14
gm/dL (males) and ?13 gm/dL (females); neutrophils

- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of screening.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT04124653
Pfizer
Not yet recruiting
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of PF-06842874 Administered as an Immediate-Release Formulation to Healthy Adult Participants and an Open-Label Assessment of the Relative Bioavailability of a Modified-Release Formulation of PF-06842874
Brief SummaryThis study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral doses as an immediate-release formulation to healthy adult participants. Part B of this study will evaluate the relative bioavailability of a modified-release formulation of PF-06842874 for its potential use in future clinical studies. The effect of food on PF-06842874 pharmacokinetics may also be evaluated in this study.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
participant- and investigator-blind, sponsor-open

Primary Purpose: Basic Science

Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: PF-06842874
    Single dose administration of PF-06842874
  • Drug: Placebo
    Single dose administration of placebo
  • Drug: Relative Bioavailability
    Relative bioavailability assessment of modified-release formulation
Study Arms  ICMJE
  • Experimental: PF-06842874/Placebo
    Single dose administration of PF-06842874 or placebo
    Interventions:
    • Drug: PF-06842874
    • Drug: Placebo
  • Experimental: Relative Bioavailability
    Determination of relative bioavailability of modified-release formulation relative to immediate-release formulation
    Intervention: Drug: Relative Bioavailability
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 24, 2020
Estimated Primary Completion DateFebruary 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • Any condition possibly affecting drug absorption.
  • History of human immunodeficiency virus infection (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
  • Participants with benign ethnic neutropenia or cyclic neutropenia.
  • Other acute or chronic medical or psychiatric condition.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
  • A positive urine drug test.
  • Screening supine blood pressure (BP) ?140 mmHg (systolic) or ?90 mmHg (diastolic), following at least 5 minutes of supine rest.
  • Baseline 12-lead standard electrocardiogram (ECG) that demonstrates clinically relevant abnormalities.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ?1.25× upper limit of normal (ULN); total bilirubin level ?1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ?ULN; hemoglobin ?14 gm/dL (males) and ?13 gm/dL (females); neutrophils <1500 cells/mm3.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
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 NCT04124653
Other Study ID Numbers  ICMJE C4041001
Has Data Monitoring CommitteeNo
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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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