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

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ClinicalTrials.gov Identifier: NCT01217918
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 1 mg Drug: 5 mg Drug: 10 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. [ Time Frame: Day 1 to Follow-up ]
  2. Mean change from baseline in vital signs (blood pressure and heart rate) measurements [ Time Frame: Baseline to Follow-up ]
  3. Mean change from baseline in 12-lead ECG parameters [ Time Frame: Baseline to Follow-up ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Volunteers
  • Japanese

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01217918     History of Changes
Other Study ID Numbers: A6631027
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011

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