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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/5/2014
Start Date:May 2013
End Date:April 2014
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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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.


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.
We found this trial at
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New Haven, Connecticut 06504
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New Haven, CT
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