Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07127926
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Belumosudil — DRUG
    Given by PO

Study Details

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).

Key Dates

First listed
Aug 17, 2025
Start date
Feb 9, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Safety and adverse events (AEs [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Amin Alousi, MD
[email protected]
713-745-8613
Amin Alousi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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