Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06305591 · 4 trials · 1 indication
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline in a 2 minute assessment.
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.
| Arm | Type | Description |
|---|---|---|
| PF-06305591 Dose 1 | EXPERIMENTAL | - |
| PF-06305591 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Multiple Dose: Cohort 1 | EXPERIMENTAL | - |
| Multiple Dose: Cohort 2 | EXPERIMENTAL | - |
| Multiple Dose: Cohort 3 | EXPERIMENTAL | - |
| Multiple Dose: Cohort 4 | EXPERIMENTAL | - |
| Relative Bioavilability: Cohort 1 | EXPERIMENTAL | - |
| PF-06305591 | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Single ascending oral doses in fasted conditions |
| Cohort 2 | EXPERIMENTAL | Single ascending oral doses in fasted conditions |
| Cohort 3 | EXPERIMENTAL | Single ascending oral doses in fed conditions |
| Name | Type | Description |
|---|---|---|
| PF-06305591 | DRUG | single Dose |
| Placebo | DRUG | Single Dose |
| Capsaicin challenge | OTHER | 110 mg capsaicin cream (Axsain®) will be applied topically at each visit. |
Inclusion Criteria: * Healthy male subjects 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 pressure and pulse rate measurement, 12-lead ECG and clinical l...
PF-06305591 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development, studied in healthy volunteers. All four clinical trials for PF-06305591 have been completed, with a total enrollment of 105 participants.
PF-06305591 is being studied for use in healthy volunteers to assess its safety, tolerability, pharmacokinetics, and effects on pain responses. Clinical trials have evaluated its impact on capsaicin-induced neurogenic flare and pain intensity evoked by cold, though it is not approved for any specific indication.
PF-06305591 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule currently in Phase 1 clinical development.
PF-06305591 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four Phase 1 trials have been completed, with no active trials currently ongoing.
PF-06305591 has been studied in four completed Phase 1 clinical trials: NCT01747941, NCT01776619, NCT01797796, and NCT01812265. These trials enrolled healthy volunteers in Belgium and assessed safety, tolerability, pharmacokinetics, and pain-related effects. All trials are completed.