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Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

NCT07556484 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-08-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ulrich Specks, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556484 on ClinicalTrials.gov