The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Avacopan capsules will be solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogatric tube.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in Avacopan blood level over time
The primary objective of this study is to determine the blood (serum) level changes of Avacopan over time (pharmacokinetics) when Avacopan capsules are solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogastric tube. Blood will be drawn pre-dose, post-dose 30 minutes, 1-hour, 2-hour, 4-hour, and 6-hour for the first dose and pre-dose for the remaining 72 hours and stored for analysis.
Time frame: 72 hours
Measure in Markers of Neutrophil Activation on Serum Samples
The exploratory objective is to measure changes in markers of neutrophil activation on serum samples (such as neutrophil elastase and/or neutrophil gelatinase-associated lipocalin (NGAL)) collected during the conduct of this study. This will not cause any additional burden to the subject. Samples will be collected from the one research blood draw already being performed per visit.
Time frame: 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.