Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be a Proof of Mechanism (POM) study to establish evidence of central pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04455242 18 mg | Experimental | Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge |
|
| Placebo | Placebo Comparator | Subjects in this arm will receive placebo prior to spiradoline challenge. |
|
| PF-04455242 30 mg | Experimental | Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04455242 | Drug | Single oral 18 mg dose of PF-04455242. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline area under the serum PRL concentration time curve from 0 to 120 minutes after intramuscular administration of PF 00345768 (spiradoline). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to peak of serum PRL concentration. | 1 week | |
| Change from baseline to peak of plasma ACTH concentration. | 1 week | |
| Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| spiradoline |
| Drug |
Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day. |
|
| Placebo | Other | Oral placebo. |
|
| spiradoline | Drug | Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day. |
|
| PF-04455242 | Drug | Single 30 mg oral dose of PF-04455242. |
|
| spiradoline | Drug | Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day. |
|
| 1 week |
| Plasma concentrations of PF 04455242. | 1 week |
| Clinical monitoring of safety and tolerability will include physical exam and neurological assessment, clinical safety laboratory results, 12 lead ECGs, vital signs, suicidality assessment, and adverse event monitoring | 1 week |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C568463 | 2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine |
| C051272 | spiradoline |
Not provided
Not provided
Not provided