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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dosing | Experimental | Single doses of CP-601,927 (1, 2 or 3 mg) or placebo |
|
| Multiple dosing | Experimental | Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-601,927 | Drug | Single dose of 1 mg CP-601,927 given as oral 1 mg tablets |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| CP-601,927 |
| Drug |
Single dose of 2 mg CP-601,927 given as oral 1 mg tablets |
|
| CP-601,927 | Drug | Single dose of 3 mg CP-601,927 given as oral 1 mg tablets |
|
| Placebo | Drug | Single dose of placebo given as a matching number of oral tablets |
|
| CP-601,927 | Drug | Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days |
|
| Placebo | Drug | Multiple doses of placebo given as a matching number of oral tablets |
|