Approval Probability
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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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug has been studied in early-stage trials to evaluate its safety and tolerability, but it is not yet approved for any medical use.
PF-04308515 is being studied for use in healthy volunteers, primarily to assess its safety, tolerability, and pharmacological effects. It is not intended for a specific disease indication at this stage. The drug is in Phase 1 clinical trials, which focus on establishing initial safety profiles in humans.
PF-04308515 is being developed by Pfizer, Inc., a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
PF-04308515 is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. All completed trials for PF-04308515 are Phase 1 studies, which are designed to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.
PF-04308515 has been studied in three completed Phase 1 clinical trials: NCT00990015, a single-dose escalation study in healthy volunteers; NCT01101932, a multiple-dose escalation trial; and NCT01199029, a single-dose study comparing PF-04308515 and prednisone on carbohydrate metabolism. All trials were conducted in the United States.
PF-04308515 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has only been studied in early-stage trials involving healthy volunteers, and it has not yet demonstrated efficacy or safety sufficient for regulatory approval.