Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04455242 · 3 trials · 2 indications
| 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. |
| PF-04455242 treatment | EXPERIMENTAL | - |
| 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 being studied for bipolar depression. It has been evaluated in Phase 1 clinical trials in healthy volunteers and in subjects with bipolar depression. The drug is not approved and remains in clinical development.
PF-04455242 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers and in subjects with bipolar depression.
PF-04455242 is in Phase 1 clinical development. It has completed two Phase 1 trials, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.
PF-04455242 has been studied in three completed Phase 1 trials: NCT00938301, a single rising dose study in healthy adults; NCT00956956, a multiple dose study in healthy adults; and NCT00988949, a proof of mechanism study in healthy males. All trials are completed.
No, PF-04455242 is not the same as PF-00345768. In clinical trial NCT00988949, PF-00345768 (spiradoline) was used as a challenge agent to test whether PF-04455242 could block its effects on prolactin release. They are distinct compounds.