A RANDOMIZED, DOUBLE BLIND THIRD PARTY OPEN PLACEBO-CONTROLLED EXPLORATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SINGLE DOSES OF PF-05089771 IN PATIENTS WITH PRIMARY (INHERITED) ERYTHROMELALGIA

简要总结

主要结局

次要结局

• Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771(Predose, 0.5, 2, 4, 6, and 24 hours post-dose)
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771(Predose and 0.5, 2, 4, 6, and 24 hours post dose)
• Maximum Observed Plasma Concentration (Cmax) of PF-05089771(Predose and 0.5, 2, 4, 6, and 24 hours post dose)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771(Predose and 0.5, 2, 4, 6, and 24 hours post dose)
• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to a maximum of Day 83)
• Number of Participants With Laboratory Abnormalities(Baseline up to a maximum of Day 73)
• Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature(Baseline up to a maximum of Day 83)
• Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure(Baseline up to a maximum of Day 83)
• Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG)(Baseline up to a maximum of Day 83)
• Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose(Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose)
• Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose(Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose)
• Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose(Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose)
• Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose(From 0 hour to 4 hours post-dose)
• Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose(From post EP2 to 8 hours post-dose)
• Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose(From the end of EP3 to 10 hours post dose)
• Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose(Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose)
• Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose(From 0 hour to 4 hours post-dose)
• Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose(Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose)
• Duration When PI-NRS Scores Were >5 - From Post EP3 to 10 Hours Post-dose(Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose)
• Duration When PI-NRS Scores Were >5 - From Post EP4 to 28 Hours Post-dose(After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose)
• Number of Participants With Participant's Global Satisfaction Score(At 4 hour post-dose or at time of first rescue therapy, whichever occurred first)
• Time to First Use of Rescue Therapy or Medication(Up to maximum of 24 hours post-dose)