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 |
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.
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.
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