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PF-04995274 · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo |
| Cohort 2 | EXPERIMENTAL | Subjects will be receive single oral doses of PF-04995274 not exceeding 15mg or a placebo |
| Dosing Healthy Adult | EXPERIMENTAL | Ascending Doses in Healthy Adult Volunteers |
| Dosing Healthy Elderly | EXPERIMENTAL | Dosing in Healthy Elderly volunteers |
| PF-04995274 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | Single dose 4 period cross-over, placebo insertion, with food effect |
| Optional Cohort 4 | EXPERIMENTAL | Single dose 3 period cross-over with placebo substitution |
| Name | Type | Description |
|---|---|---|
| PF-04995274 | DRUG | Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo |
| 0.1 mg PF-04995274 | DRUG | 0.1 mg PF-04995274, qd, for 14 days or placebo |
| 1 mg PF-04995274 | DRUG | 1 mg PF-04995274, qd, for 14 days or placebo |
| 10 mg PF-04995274 | DRUG | 10 mg PF-04995274, qd, for 14 days or placebo |
| 15 mg PF-04995274 | DRUG | 15 mg PF-04995274, qd, for 14 days or placebo |
| 1.0 mg PF-04995274 | DRUG | 1.0 mg PF-04995274, qd, for 14 days or placebo |
Inclusion Criteria: * For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pr...
PF-04995274 is an investigational small molecule developed by Pfizer, Inc. It has been studied in Phase 1 clinical trials in healthy adult and elderly volunteers. Its therapeutic indication has not been disclosed, and no Phase 1 trial of PF-04995274 has studied a patient population.
PF-04995274 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored all four Phase 1 trials of PF-04995274, which were conducted in the United States and Belgium.
PF-04995274 is in Phase 1 clinical development. All four of its recorded trials are Phase 1 studies, and all four are completed, with no active trials ongoing. PF-04995274 is investigational and has not been approved by the FDA for any indication.
PF-04995274 has been evaluated in four completed Phase 1 trials: NCT01193062, NCT01173757, NCT01169714, and NCT01091272. These studies enrolled 114 participants in total and examined safety, tolerability, plasma drug levels, cerebrospinal fluid sAPP-alpha changes, and brain receptor binding in healthy volunteers.
The PF-04995274 Phase 1 program studied safety, tolerability, and plasma drug concentrations after single and multiple doses in healthy adults and elderly volunteers. One trial measured changes in the cerebrospinal fluid protein sAPP-alpha, and another used PET imaging to evaluate the relationship between plasma drug levels and brain receptor binding.