Completed
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
What is being tested
PF-04965842
+ Placebo
+ PF-04965842
Drug
Who is being recruted
From 18 to 55 Years
+8 Eligibility Criteria
How is the trial designed
Basic Science Study
Placebo-ControlledPhase 1
Interventional
Study Start: May 2013
Summary
Principal SponsorPfizer
Last updated: June 20, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorPfizer
Last updated: June 20, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Absolute lymphocyte count must be greater than or equal to the lower limit of the laboratory reference range
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
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan
Show More Criteria
3 exclusion criteria prevent from participating
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
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
10 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
ExperimentalGroup IV
PlaceboGroup 5
ExperimentalGroup 6
PlaceboGroup 7
ExperimentalGroup 8
PlaceboGroup 9
ExperimentalGroup 10
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center