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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 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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
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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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
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01835197
B7451001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
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 thte study website. To get updates and notications about this trail, sign up using the form below.

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