A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Pfizer15 enrolled

Overview

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

PF-05221304DRUG

3, 10, 50 mg

PF-05221304DRUG

50 mg multiple dose

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive. * Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight \>50 kg (110 lb). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

Locations (1)

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, Japan

Outcomes

Primary Outcomes

Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Maximum observed plasma concentration (Cmax)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Time to reach Cmax (Tmax)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Terminal half life (as data permit) (t1/2)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Apparent clearance (as data permit) (CL/F)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort A: Apparent volume of distribution (as data permit) (Vz/F)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose

Cohort B: Number of Subjects experiencing an Adverse Event

Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.

Time frame: Screening up to 28 days after last dose of study medication

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cohort A: Number of Subjects experiencing an Adverse Event

Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.

Time frame: Screening up to 28 days after last dose of study medication

Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose

Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)