Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 1 mg; Drug: 5 mg; Drug: 10 mg

• Registration Number: NCT01217918
• Lead Sponsor: Pfizer

Brief Summary

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy Volunteers
• Japanese

Exclusion Criteria

• Subjects with clinically significant skin lesions
• Subjects with known tuberculosis infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	1 mg	PH-797804
Cohort 2	5 mg	PH-797804
Cohotr 3	10 mg	PH-797804

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.	Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements	Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters	Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax	Days 1 and 10

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Glendale, California, United States