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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD Cohorts 1-8 Experimental Arm

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

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.

SAD Cohorts 1-8 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.

MAD Cohorts 3 through 5 Experimental Arm

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.

MAD Cohorts 3 through 5 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.

MAD Cohorts 6 and 7 Experimental Arm

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.

MAD Cohorts 6 and 7 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.

MAD Cohort 8 Experimental Arm

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.

MAD Cohort 8 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.

MAD Cohort 9 Experimental Arm

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.

MAD Cohort 9 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.

Interventions

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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.

Intervention Type DRUG

Placebo

Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.

Intervention Type DRUG

PF-04965842

Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.

Intervention Type DRUG

Placebo

Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.

Intervention Type DRUG

PF-04965842

Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.

Intervention Type DRUG

Placebo

Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.

Intervention Type DRUG

PF-04965842

Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.

Intervention Type DRUG

Placebo

Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.

Intervention Type DRUG

PF-04965842

Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.

Intervention Type DRUG

Placebo

Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes