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
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 April 16, 2014