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

Summary

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.

Conditions

• Healthy

Interventions

DRUG

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.

DRUG

Placebo

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

DRUG

PF-04965842

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

DRUG

Placebo

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

DRUG

PF-04965842

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

DRUG

Placebo

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

DRUG

PF-04965842

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

DRUG

Placebo

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

DRUG

PF-04965842

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

DRUG

Placebo

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

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• United States

Study Locations