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

Pfizer30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

1 mgDRUG

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

5 mgDRUG

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

10 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Volunteers * Japanese Exclusion Criteria: * Subjects with clinically significant skin lesions * Subjects with known tuberculosis infection

Locations (2)

Pfizer Investigational Site

Culver City, California, United States

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.

Time frame: Day 1 to Follow-up

Mean change from baseline in vital signs (blood pressure and heart rate) measurements

Time frame: Baseline to Follow-up

Mean change from baseline in 12-lead ECG parameters

Time frame: 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

Time frame: Days 1 and 10

Data from ClinicalTrials.gov

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