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OpenTrials
Completed

NCT Number: NCT01217918

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Culver City, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Volunteers
  • Japanese

Exclusion criteria

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

Treatment and study plan

1 mg

Drug

1 mg or placebo a material sparing tablet per day for 10 days

5 mg

Drug

5 mg or placebo as material sparing tablet per day for 10 days

10 mg

Drug

10 mg or placebo as a material sparing tablet per day for 10 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2010
Registry last updated
Feb 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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