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
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01835197
- Run by
- Pfizer
- People needed
- 79
- Starts
- 2013-05-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2014-06-20
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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