Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit.
Subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat CRS symptoms during the course of the study.
Subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding.
No clinically significant abnormality identified on the medical or laboratory evaluation.
You may not be if
Subject has primary headache disorder.
Subject has history of nasal or facial surgery within the 6 months prior to screening.
Subject has ongoing rhinitis medicamentosa.
Subject has diagnosed or suspected invasive fungal rhinosinusitis.
Subject is currently receiving aspirin desensitization or maintenance therapy for Samter's Triad.
Subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes).
Body Mass Index \> 35.0kg/m2
Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
Subjects taking/using excluded therapies.
Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
Planned participation in any other investigational clinical trial while participating in this clinical trial.
