Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

Purpose

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.

Conditions

  • Diffuse Alveolar Hemorrhage
  • Antineutrophil Cytoplasmic Antibody Positive Vasculitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. - Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary. - Minimum BVAS-WG of 3. - Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).

Exclusion Criteria

  • 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. - Concomitant use of a strong CYP3A4 inhibitor. - Aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphatase, or total bilirubin elevation >2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan. - Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection. - Active serious infection, including localized infection. - Pregnancy and breastfeeding

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Avacopan 		Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube.
  • Drug: Avacopan
    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.
    Other names:
    • Tavneos

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Josie Baum
507-422-9010
baum.josephine@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Josie Baum
507-422-9010
baum.josephine@mayo.edu