Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04455242 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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. |
| Treatment | ACTIVE_COMPARATOR | 2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion. |
| Name | Type | Description |
|---|---|---|
| PF-04455242 | DRUG | Single oral 18 mg dose of PF-04455242. |
| spiradoline | DRUG | Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day. |
| Placebo | OTHER | Oral placebo. |
Inclusion Criteria: * Healthy male subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical l...
PF-04455242 is an investigational small molecule developed by Pfizer, Inc. (PFE) for bipolar depression. It has been studied in Phase 1 clinical trials, including a first-in-human safety study and a proof-of-mechanism study. It is not approved for any indication and remains in early clinical development.
PF-04455242 is being studied for the treatment of bipolar depression. It has been evaluated in Phase 1 trials that enrolled healthy adult volunteers, including a proof-of-mechanism study in Singapore and a first-in-human study in the United States. It is investigational and not approved for use.
PF-04455242 is made by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the developer of the compound and sponsored both Phase 1 clinical trials of the drug.
PF-04455242 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are ongoing. The drug has not been approved by the FDA or any regulatory agency for bipolar depression or any other indication.
PF-04455242 has been studied in two completed Phase 1 trials. NCT00988949 was a proof-of-mechanism study in bipolar depression conducted in Singapore with 24 male healthy volunteers. NCT00938301 was a first-in-human study evaluating safety, tolerability, and pharmacokinetics in 18 healthy adult volunteers in the United States.
PF-04455242 is a small molecule studied in a proof-of-mechanism trial that measured its ability to block spiradoline (PF-00345768) stimulated prolactin release. This design was used to assess the drug's pharmacological activity in healthy volunteers. The specific molecular target of PF-04455242 is not publicly disclosed.