Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

NCT07556484 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-009571
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Secondary Outcomes (1)

• Measure in Markers of Neutrophil Activation on Serum Samples

  72 hours

Study Arms (1)

Avacopan

EXPERIMENTAL

Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube.

Drug: Avacopan

Interventions

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.

Also known as: Tavneos

Avacopan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

avacopan

Study Officials

• Ulrich Specks, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josie Baum

CONTACT

507-422-9010; baum.josephine@mayo.edu

Michael Stachowitz

CONTACT

stachowitz.michael@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)