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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Avacopan |
Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube. |
|
Recruiting Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic