Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01812265 | Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects | PHASE1 | COMPLETED | 16 | — | — | Jun 1, 2013 | Aug 1, 2013 | Sep 17, 2013 | 1 | Belgium |
| NCT01776619 | Safety and Tolerability Study of Multiple Doses of PF-06305591 | PHASE1 | COMPLETED | 43 | — | — | Apr 1, 2013 | Nov 1, 2013 | Dec 3, 2013 | 1 | Belgium |
| NCT01797796 | Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare | PHASE1 | COMPLETED | 16 | — | — | Apr 1, 2013 | Jul 1, 2013 | Aug 20, 2013 | 1 | Belgium |
| NCT01747941 | Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects | PHASE1 | COMPLETED | 30 | — | — | Nov 1, 2012 | May 1, 2013 | May 23, 2013 | 1 | Belgium |
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...