A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

Pfizer

Overview

This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Conditions

Healthy

Interventions

CP-601,927DRUG

Single dose of 1 mg CP-601,927 given as oral 1 mg tablets

CP-601,927DRUG

Single dose of 2 mg CP-601,927 given as oral 1 mg tablets

CP-601,927DRUG

Single dose of 3 mg CP-601,927 given as oral 1 mg tablets

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive. * Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Females of childbearing potential. * Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations \>100 ng/mL at any time during the study will be excluded.

Outcomes

Primary Outcomes

Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927

Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927

Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927

Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days

Time frame: Day1-7

Suicidality assessment after single dose of 1 mg CP-601,927

Time frame: Day 0, 0 and 2 hours post-dose

Suicidality assessment after single dose of 2 mg CP-601,927

Time frame: Day 0, 0 and 2 hours post-dose

Suicidality assessment after single dose of 3 mg CP-601,927

Time frame: Day 0, 0 and 2 hours post-dose

Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days

Time frame: Day1-7

Data from ClinicalTrials.gov

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