Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07556484
Phase
PHASE1
Status
Recruiting
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Conditions

  • Antineutrophil Cytoplasmic Antibody Positive Vasculitis
  • Diffuse Alveolar Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in Avacopan blood level over time [ Time Frame: 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Josie Baum
[email protected]
507-422-9010
Ulrich Specks, MD (PRINCIPAL_INVESTIGATOR)

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