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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01217918
First received: October 7, 2010
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: 1 mg
Drug: 5 mg
Drug: 10 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. [ Time Frame: Day 1 to Follow-up ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vital signs (blood pressure and heart rate) measurements [ Time Frame: Baseline to Follow-up ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in 12-lead ECG parameters [ Time Frame: Baseline to Follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Days 1 and 10 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
PH-797804
Drug: 1 mg
1 mg or placebo a material sparing tablet per day for 10 days
Experimental: Cohort 2
PH-797804
Drug: 5 mg
5 mg or placebo as material sparing tablet per day for 10 days
Experimental: Cohotr 3
PH-797804
Drug: 10 mg
10 mg or placebo as a material sparing tablet per day for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Volunteers
  • Japanese

Exclusion Criteria:

  • Subjects with clinically significant skin lesions
  • Subjects with known tuberculosis infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217918

Locations
United States, California
Pfizer Investigational Site
Culver City, California, United States, 90232
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01217918     History of Changes
Other Study ID Numbers: A6631027
Study First Received: October 7, 2010
Last Updated: February 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PH-797804
Japanese
Phase 1
multiple dose study

ClinicalTrials.gov processed this record on October 23, 2014