Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The primary objective of the study is to evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female subjects ≥ 18 years of age with allogeneic HSCT
Locations
United States
Texas
The University of Texas M. D. Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Amin Alousi, MD
aalousi@mdanderson.org
(713) 745-8613
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 8
Treatments
Experimental: Belumosudil
On Days 0 to 7, you will:~• Take whole belumosudil tablet by mouth 1 time a day at same time of the day.~On Day 7, you will then have your 1st pharmacokinetic visit at MD Anderson:~• Blood samples (about 1 teaspoon) will be collected before dosing, and 0.5, 1, 2, 4, 8, 12, and 24 hours after belumosudil dosing.~On Days 8 to 14, you will:~• Take crushed belumosudil tablet by mouth 1 time a day at same time of the day.~On Day 14, you will then have your 2nd pharmacokinetic visit to MD Anderson:~• Blood samples (about 1 teaspoon) will be collected before dosing, and 0.5, 1, 2, 4, 8, 12, and 24 hours after belumosudil dosing.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center