Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD
Purpose
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).
Condition
- Chronic Graft Versus Host Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and female subjects ≥ 18 years of age with allogeneic HSCT
Exclusion Criteria
- Receiving an investigational GVHD treatment within 28 days of study entry; (2) active acute GVHD; and (3) taking any medication known to be CYP3A4 inducers. - Pregnancy is an exclusion criterion for stem cell transplant. Pregnant women are not included in this study. Non-viable neonates will not be included in this study. Patients with cognitive impairments will not be included in this study. Patients aged less than 18 years old will not be included.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
The University of Texas M. D. Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
Detailed Description
Primary Objective: To evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).