Complex Study Conduct at Novum
Novum recently conducted two complex Pharmacokinetic Pharmacodynamic (PK/PD) studies in Las Vegas for a nasal spray product. One of the studies enrolled a total of 70 subjects. Five cohorts of 14 subjects were enrolled. The study involved dose administration and PK/PD profiles on five consecutive days. On each dosing day, 20 blood samples were collected for PK analysis over an eight hour time period. In addition, the following Pharmacodynamic measurements were collected over the eight hour time period:
- Ambulatory Blood Pressure Monitoring
- Continuous ECG monitoring via a Holter Monitor
- Blood Pressure/Respiratory Rate/ Temperature/Heart Rate
- Nasal Irritation Assessments
- Smell Tests using the NIH Toolbox Odor Identification Test
- Visual Analogue Scale for acute nose pain
- Nasal Photography
- Total Nasal Symptom Score
- Over the course of the study a total of 23,100 Pharmacodynamic Assessments were made.
Study Drug Preparation
The pharmacy recently completed the preparation of a nasal spray for a Pharmacokinetic Study. To prepare the nasal spray, an excipient stock solution and drug stock solution were prepared. Preparation involved precise measurements of solid and liquid components to make the stock solutions. Preparation of the drug stock solution required pH titration to get the compound into solution. Once the stock solutions were made, the next step was to prepare five concentrations of the drug product. This involved precise measurements of all components and a final pH check. The nasal spray was to be delivered via a unit dose device. The pharmacy team was responsible for the preparation and assembly of the device which would deliver a single 100 microliter dose to the subject.
Patient Populations in the Clinic
Novum recently completed a PK/PD Study enrolling subjects with seasonal allergic rhinitis. During the screening period, seasonal allergies to tree or grass were confirmed through the use of standardized allergen solutions. Novum also completed a Proof of Concept Study in Rosacea Patients.