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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CP-601,927
* Drug: CP-601,927
* Drug: CP-601,927
* Drug: Placebo
* Drug: CP-601,927
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dosing<br>Single doses of CP-601,927 (1, 2 or 3 mg) or placebo | Drug: CP-601,927<br>* Single dose of 1 mg CP-601,927 given as oral 1 mg tablets<br>Drug: CP-601,927<br>* Single dose of 2 mg CP-601,927 given as oral 1 mg tablets<br>Drug: CP-601,927<br>* Single dose of 3 mg CP-601,927 given as oral 1 mg tablets<br>Drug: Placebo<br>* Single dose of placebo given as a matching number of oral tablets<br>|
| Experimental: Multiple dosing<br>Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo | Drug: CP-601,927<br>* Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days<br>Drug: Placebo<br>* Multiple doses of placebo given as a matching number of oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | 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 |  | Day1-7 | 
| Suicidality assessment after single dose of 1 mg CP-601,927 |  | Day 0, 0 and 2 hours post-dose | 
| Suicidality assessment after single dose of 2 mg CP-601,927 |  | Day 0, 0 and 2 hours post-dose | 
| Suicidality assessment after single dose of 3 mg CP-601,927 |  | 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 |  | Day1-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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927, Phase 1, Pharmacokinetics, Healthy, Japanese, Non-smokers, Major Depressive Disorder, CP-601