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 developed by Pfizer, Inc. It has been studied in Phase 1 clinical trials involving healthy volunteers. Its therapeutic indication has not been disclosed. All four of its recorded trials are completed, and no trials are currently active.
PF-06305591 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 the compound, which were conducted in Belgium.
PF-06305591 is in Phase 1 development. All four of its clinical trials were Phase 1 studies, and all four are completed. No later-phase trials have been recorded, and no trials are currently active.
PF-06305591 has been evaluated in four completed Phase 1 trials: NCT01812265, which used a cold pressor test to assess pain intensity in healthy male subjects; NCT01797796, which examined capsaicin and capsaicin/heat-induced neurogenic flare; NCT01776619, a multiple-dose safety and tolerability study; and NCT01747941, a safety, tolerability, and pharmacokinetics study.
The four completed Phase 1 trials of PF-06305591 enrolled a total of 105 participants. Enrollment across the individual studies ranged from 16 to 43 healthy volunteers. The trials were conducted in Belgium and included both male-only and mixed-sex study populations.
Yes. The PF-06305591 Phase 1 program included randomized, double-blind, controlled trials. The studies enrolled healthy volunteers and assessed safety, tolerability, pharmacokinetics, and pain-related endpoints such as cold pressor response and capsaicin-induced neurogenic flare.