NCT03530995 is a Phase 1 clinical trial of Belumosudil in Drug-drug Interaction, sponsored by Kadmon Corporation, LLC.

Who is sponsoring NCT03530995?

NCT03530995 is sponsored by Kadmon Corporation, LLC.

What drugs are being tested in NCT03530995?

Interventions in NCT03530995: Belumosudil, Itraconazole, Rabeprazole, Rifampicin, Omeprazole.

What condition does NCT03530995 study?

NCT03530995 studies Drug-drug Interaction, Autoimmune Diseases, Fibrotic Disease.

Is NCT03530995 still recruiting?

NCT03530995 is currently completed. Last updated 25 May 2022.

Are results published for NCT03530995?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-05-25 · How we verify

NCT03530995

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Completed Phase 1 Results posted Last updated 25 May 2022

What this trial tests

Phase 1 trial testing Belumosudil in Drug-drug Interaction in 73 participants. Completed in 8 February 2019.

Timeline

9 April 2018

Primary endpoint
8 February 2019

8 February 2019

Quick facts

Lead sponsor	Kadmon Corporation, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	73
Start date	9 April 2018
Primary completion	8 February 2019
Estimated completion	8 February 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

Belumosudil (BELUMOSUDIL) — full drug profile →
Itraconazole — full drug profile →
Rabeprazole — full drug profile →
Rifampicin
Omeprazole (omeprazole) — full drug profile →

Conditions studied

Drug-drug Interaction — all drugs for Drug-drug Interaction →
Autoimmune Diseases — all drugs for Autoimmune Diseases →
Fibrotic Disease — all drugs for Fibrotic Disease →

Sponsor

Kadmon Corporation, LLC — full company profile →

Who can join

Adults 18 to 55, male only, with Drug-drug Interaction or Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1 Primary · Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose

Maximum concentration (Cmax) of the parent drug, KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) for belumosudil alone, belumosudil + itraconazole, belumosudil + rabeprazole, and belumosudil + rifampicin at 0 to 48 hours post-dose

Parent Drug KD025

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	1770	± 31.3
Part 1, Period 2: Belumosudil + Itraconazole	2130	± 31.0
Part 1, Period 3: Belumosudil + Rabeprazole	227	± 58.4
Part 1, Period 4: Belumosudil + Rifampicin	712	± 35

KD025m2

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	337	± 54.7
Part 1, Period 2: Belumosudil + Itraconazole	221	± 60.8
Part 1, Period 3: Belumosudil + Rabeprazole	23.5	± 70.7
Part 1, Period 4: Belumosudil + Rifampicin	148	± 57.3

Pharmacokinetics: Cmax of KD025m1 in Part 1 Primary · Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose

Maximum concentration (Cmax) of Metabolite 1 (KD025m1) for belumosudil alone and for belumosudil + rifampicin up to 48 hours post-dose

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	23.2	± 40.0
Part 1, Period 4: Belumosudil + Rifampicin	52.5	± 34.0

Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2 Primary · Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose

Maximum concentration (Cmax) of the parent drug (KD025), for Metabolite 1 (KD025m1), and for Metabolite 2 (KD025m2), for belumosudil alone and for belumosudil + omeprazole up to 48 hours post-dose

Cmax--1st dose: KD025

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	1790	± 34.5
Part 2, Period 2: Belumosudil + Omeprazole	575	± 145.7

Cmax--2nd dose: KD025

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	1760	± 37.0
Part 2, Period 2: Belumosudil + Omeprazole	903	± 63.8

Cmax--1st Dose: KD025m1

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	23.8	± 39.6
Part 2, Period 2: Belumosudil + Omeprazole	18.0	± 54.6

Cmax--2nd Dose: KD025m1

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	23.6	± 46.4
Part 2, Period 2: Belumosudil + Omeprazole	18.9	± 48.7

Cmax--1st Dose: KD025m2

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	282	± 75.6
Part 2, Period 2: Belumosudil + Omeprazole	72.3	± 166.8

Cmax--2nd Dose: KD025m2

Group	Value	95% CI
Part 2, Period 1: Belumosudil Alone	257	± 83.9
Part 2, Period 2: Belumosudil + Omeprazole	115	± 121.8

Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2 Primary · Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose

Area under concentration-time curve from zero hours to infinity (AUC\[0-inf\]) and from zero hours to 24 hours post-dose (AUC\[0-24)) for the parent drug KD025, and Metabolite 2, KD025m2, for subjects up to 48 hours each for Part 1 and for Part 2

AUC(0-inf): KD025

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	9080	± 33.3
Part 1, Period 2: Belumosudil + Itraconazole	11200	± 38.1
Part 1, Period 3: Belumosudil + Rabeprazole	1680	± 65.8
Part 1, Period 4: Belumosudil + Rifampicin	2500	± 34.5
Part 2, Period 1: Belumosudil Only	18800	± 37.1
Part 2, Period 2: Belumosudil + Omeprazole	9880	± 59.2

AUC(0-inf): KD025m2

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	1230	± 69.5
Part 1, Period 2: Belumosudil + Itraconazole	843	± 73.7
Part 1, Period 3: Belumosudil + Rabeprazole	174	± 11.1
Part 1, Period 4: Belumosudil + Rifampicin	396	± 50.2
Part 2, Period 1: Belumosudil Only	1900	± 90.4
Part 2, Period 2: Belumosudil + Omeprazole	1110	± 30.3

AUC(0-24): KD025

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	8430	± 30.5
Part 1, Period 2: Belumosudil + Itraconazole	10400	± 35.8
Part 1, Period 3: Belumosudil + Rabeprazole	1510	± 60.7
Part 1, Period 4: Belumosudil + Rifampicin	2490	± 34.1
Part 2, Period 1: Belumosudil Only	16800	± 36.4
Part 2, Period 2: Belumosudil + Omeprazole	7970	± 58.9

AUC(0-24): KD025m2

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	1100	± 63.7
Part 1, Period 2: Belumosudil + Itraconazole	745	± 70.7
Part 1, Period 3: Belumosudil + Rabeprazole	110	± 84.0
Part 1, Period 4: Belumosudil + Rifampicin	376	± 56.7
Part 2, Period 1: Belumosudil Only	1950	± 82.3
Part 2, Period 2: Belumosudil + Omeprazole	767	± 115.3

Pharmacokinetics: AUC(0-24) of KD025m1 for Part 1 and for Part 2 Primary · Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12, and 24 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22, and 24 hours post-dose

Area under concentration-time curve from zero hours to 24 hours post-dose (AUC\[0-24\]) for Metabolite 1, KD025m1, for subjects in Part 1 and for subjects in Part 2

Group	Value	95% CI
Part 1, Period 1: Belumosudil Alone	75.6	± 42.1
Part 1, Period 4: Belumosudil + Rifampicin	148	± 41.9
Part 2, Period 1: Belumosudil Alone	138	± 91.3
Part 2, Period 2: Belumosudil + Omeprazole	91.5	± 76.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1, Period 1: Belumosudil Only

Serious: 0/35 (0%)

Deaths: 0/35

Part 1, Period 2: Belumosudil + Itraconazole

Serious: 1/35 (3%)

Deaths: 0/35

Part 1, Period 3: Belumosudil +Rabeprazole

Serious: 0/33 (0%)

Deaths: 0/33

Part 1, Period 4: Belumosudil + Rifampicin

Serious: 0/32 (0%)

Deaths: 0/32

Part 2, Period 1: Belumosudil Only

Serious: 0/38 (0%)

Deaths: 0/38

Part 2, Period 2: Belumosudil + Omeprazole

Serious: 0/38 (0%)

Deaths: 0/38

Serious adverse events (1 terms)

Reaction	System	Part 1, Period 1: Belumosu…	Part 1, Period 2: Belumosu…	Part 1, Period 3: Belumosu…	Part 1, Period 4: Belumosu…	Part 2, Period 1: Belumosu…	Part 2, Period 2: Belumosu…
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—

Other adverse events (34 terms — click to expand)

Reaction	System	Part 1, Period 1: Belumosu…	Part 1, Period 2: Belumosu…	Part 1, Period 3: Belumosu…	Part 1, Period 4: Belumosu…	Part 2, Period 1: Belumosu…	Part 2, Period 2: Belumosu…
Headache	Nervous system disorders	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Medical device site rash	General disorders	—	—	—	—	—	—
Vessel puncture site bruise	General disorders	—	—	—	—	—	—
Catheter site related reaction	General disorders	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—	—
Paronychia	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Back injury	Injury, poisoning and procedural complications	—	—	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Miliaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—	—	—

Most-reported serious reactions: Ankle fracture.

Data from ClinicalTrials.gov NCT03530995 adverse events section.

Sponsor's own description

This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka D, Le RQ, Ionan A, Li RJ, et al · · 2022 · cited 41× · PMID 35135839 · DOI 10.1158/1078-0432.ccr-21-4176
Druggable targets in the Rho pathway and their promise for therapeutic control of blood pressure.
Dee RA, Mangum KD, Bai X, Mack CP, et al · · 2019 · cited 19× · PMID 30189292 · DOI 10.1016/j.pharmthera.2018.09.001
The Physiology, Pathology, and Therapeutic Interventions for ROCK Isoforms in Diabetic Kidney Disease.
Matoba K, Takeda Y, Nagai Y, Sekiguchi K, et al · · 2020 · cited 18× · PMID 33101039 · DOI 10.3389/fphar.2020.585633

Verify or expand the search:

Other trials of Belumosudil

Trials testing the same drug.

NCT07135973 — A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Dis · Phase 4 · not yet recruiting
NCT07116031 — A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK) · Phase 2 · recruiting
NCT05567406 — Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawai · Phase 2 · withdrawn
NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
NCT06476132 — Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients · Phase 2 · recruiting

Other recruiting trials for Drug-drug Interaction

Currently open trials in the same condition.

NCT06381375 — Drug-drug Interactions With Anti-tuberculous Drugs · recruiting
NCT06682325 — Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients · recruiting
NCT05044962 — Kuwa Free! - Live Free! · NA · recruiting

Other Kadmon Corporation, LLC trials

Trials by the same sponsor.

NCT04735822 — A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability · EARLY_PHASE1 · completed
NCT03907540 — Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025 · Phase 1 · completed
NCT03096080 — A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Pol · Phase 1 · completed
NCT02852967 — A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Se · Phase 2 · completed
NCT02688647 — A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03530995 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kadmon Corporation, LLC
Last refreshed: 25 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03530995.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing