Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

ConditionsDiffuse Alveolar Hemorrhage Antineutrophil Cytoplasmic Antibody Positive Vasculitis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA).

Positivity for ANCA, directed against PR3 or MPO.

Diffuse alveolar hemorrhage.

Respiratory failure requiring mechanical ventilation.

Disqualifiers

Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference.

Allergies: History of severe allergic reaction to avacopan

History of documented anti-glomerular basement membrane disease (anti-GBM disease)

Previous administration of avacopan within the last 5 days.

Trial design

Design model

Single group

Treatments tested in this trial

Avacopan
Drug
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.

Treatment groups

6 Participants

are divided into 1 treatment group

Group A: AvacopanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change 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

Secondary outcomes

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

Sponsors and contacts

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Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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