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

PHASE1CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

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.

Trial Locations (1)

06511

Pfizer Investigational Site, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01835197 - 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 | Biotech Hunter | Biotech Hunter