Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04308515 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| (Part 1) 10 mg PF-04308515 (8hrs) | EXPERIMENTAL | - |
| (Part 1) 10 mg PF-04308515 (12hrs) | EXPERIMENTAL | - |
| (Part 1) 5 mg Prednisone | ACTIVE_COMPARATOR | - |
| (Part 2) X mg PF-04308515 | EXPERIMENTAL | - |
| (Part 2) Y mg PF-04308515 | EXPERIMENTAL | - |
| (Part 2) 5 mg Prednisone | ACTIVE_COMPARATOR | - |
| (Part 2) 20 mg Prednisone | ACTIVE_COMPARATOR | - |
| (Part 1) PF-04308515 | EXPERIMENTAL | - |
| (Part 1) Solution Placebo | PLACEBO_COMPARATOR | - |
| (Part 2) PF-04308515 Tablet | EXPERIMENTAL | - |
| PF-04308515 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04308515 | DRUG | 10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT) |
| Prednisone | DRUG | 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
| Placebo | DRUG | Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days. |
| PF-04308515 Tablet | DRUG | Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day. |
Inclusion Criteria: * BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg Exclusion Criteria: * Fasting glucose above the limits of the reference range for healthy individuals * "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance * Severe acute or chronic med...
PF-04308515 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in Phase 1 clinical trials in healthy adult volunteers rather than in patients with a specific disease. No therapeutic indication for PF-04308515 has been disclosed.
PF-04308515 is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored all three of the Phase 1 trials of PF-04308515 conducted in the United States.
PF-04308515 is in Phase 1 development. All three of its clinical trials were Phase 1 studies, and all three are now completed. There are no active trials of PF-04308515, and the drug is investigational rather than approved.
PF-04308515 has been evaluated in three completed Phase 1 trials: NCT00990015, a single-dose escalation study in healthy volunteers; NCT01101932, a multiple-dose escalation trial in healthy volunteers; and NCT01199029, a single-dose study comparing PF-04308515 with prednisone and its effect on carbohydrate handling.
The three completed Phase 1 trials of PF-04308515 enrolled 103 participants in total. NCT01101932 enrolled 58 healthy volunteers, NCT00990015 enrolled 27, and NCT01199029 enrolled 18. All participants were adults aged 18 years and older, and all trials were conducted in the United States.
Yes. The PF-04308515 Phase 1 program used randomized, double-blind designs with active control. The trials enrolled healthy adult volunteers, and one study, NCT01199029, used prednisone as the active comparator while examining effects on carbohydrate measures.