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NCT Number: NCT07127926

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

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).

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Key information

Conditions

Chronic Graft Versus Host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Amin Alousi, MD

CONTACT

[email protected]

713-745-8613

Amin Alousi, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belumosudil

Drug

Given by PO

Primary outcomes

  1. Safety and adverse events (AEs

    Time frame: Through study completion; an average of 1 year

    Intra patient change in pharmacokinetic parameters will be determined. In addition, it will be evaluated whether crushing the tablet would have clinically significant change in AUC or Cmax, Tmax, which might impact efficacy or safety of belumosudil based on prior belumosudil pharmacokinetic studies. Due to small number of patients in this study, we don't plan to evaluate the impact of crushed belumosudil tablets pharmacokinetics with long-term outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Amin Alousi, MD

CONTACT

[email protected]

(713) 745-8613

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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