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First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects

Last updated on December 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
ClinicalTrials.gov_Inquiries[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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/or female subjects between the ages of 18 and 55 years, inclusive.

- Females must be of non-child bearing potential and either at least 1 year post
menopausal (FSH ≥40 IU/L), or have documented hysterectomy (with or without bilateral
oophrectomy) at least 6 months prior to study day

- Subjects willing to defer receiving prophylactic immunizations (e.g. influenza or
pneumococcal vaccines) during the study.

- Absolute lymphocyte count must be greater than or equal to the lower limit of the
laboratory reference range.

- Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan.

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, , pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic
disease (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing).

- History of hepatitis or positive testing for human immunodeficiency virus (HIV),
hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab) or hepatitis C
antibodies (HCV).

- Clinically significant abnormality on chest X-ray performed at screening or within 3
months of screening date; or history of tuberculosis or active or latent or
inadequately treated infection.

NCT01835197
Pfizer
Completed
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects

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Descriptive Information
Brief Title  ICMJE First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects
Official Title  ICMJE A Phase 1, Within Cohort, Randomized, Double Blind, Third-Party Open, Placebo-Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-04965842 In Healthy Western and Japanese Subjects
Brief Summary This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04965842
    Subjects will receive single doses of 3, 10, 30, 100, 200, 400, or 800 mg of PF-04695842 (solution or suspension) in a dose escalation format.
  • Drug: Placebo
    Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.
  • Drug: PF-04965842
    Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.
  • Drug: Placebo
    Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.
  • Drug: PF-04965842
    Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.
  • Drug: Placebo
    Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.
  • Drug: PF-04965842
    Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.
  • Drug: Placebo
    Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.
  • Drug: PF-04965842
    Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.
  • Drug: Placebo
    Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.
Study Arms  ICMJE
  • Experimental: SAD Cohorts 1-8 Experimental Arm
    Intervention: Drug: PF-04965842
  • Placebo Comparator: SAD Cohorts 1-8 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohorts 3 through 5 Experimental Arm
    Intervention: Drug: PF-04965842
  • Placebo Comparator: MAD Cohorts 3 through 5 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohorts 6 and 7 Experimental Arm
    Intervention: Drug: PF-04965842
  • Placebo Comparator: MAD Cohorts 6 and 7 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohort 8 Experimental Arm
    Intervention: Drug: PF-04965842
  • Placebo Comparator: MAD Cohort 8 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohort 9 Experimental Arm
    Intervention: Drug: PF-04965842
  • Placebo Comparator: MAD Cohort 9 Placebo Arm
    Intervention: Drug: Placebo
Publications * Peeva E, Hodge MR, Kieras E, Vazquez ML, Goteti K, Tarabar SG, Alvey CW, Banfield C. Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study. Br J Clin Pharmacol. 2018 Aug;84(8):1776-1788. doi: 10.1111/bcp.13612. Epub 2018 May 24.


*   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: June 19, 2014)
79
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2013)
56
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Females must be of non-child bearing potential and either at least 1 year post menopausal (FSH ?40 IU/L), or have documented hysterectomy (with or without bilateral oophrectomy) at least 6 months prior to study day
  • Subjects willing to defer receiving prophylactic immunizations (e.g. influenza or pneumococcal vaccines) during the study.
  • Absolute lymphocyte count must be greater than or equal to the lower limit of the laboratory reference range.
  • Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, , pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab) or hepatitis C antibodies (HCV).
  • Clinically significant abnormality on chest X-ray performed at screening or within 3 months of screening date; or history of tuberculosis or active or latent or inadequately treated infection.
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 NCT01835197
Other Study ID Numbers  ICMJE B7451001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 June 2014

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:

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1-800-718-1021

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