CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Belumosudil 200 mg tablet +2 moredrug
Likely dose
Belumosudil 200 mg tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03907540
NCT03907540Phase 1Completed

Open-label, 2-part Study Designated to Assess the Absolute Bioavailability of KD025 and to Determine the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-KD025 in Healthy Male Subjects

Kadmon Corporation, LLC·interventional·Posted Apr 9, 2019·Updated May 26, 2022

In Brief

A Phase 1 clinical trial evaluating Belumosudil 200 mg tablet, [14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose, and 1 other intervention for Autoimmune Diseases and Fibrosis. Completed, enrolled 5 participants across 1 site.

Detailed Summary

Human, absorption, metabolism and excretion study of belumosudil (KD025)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsQuotient Sciences

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 9, 2019
Enrollment StartApr 5, 2019
Primary CompletionMay 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.2 years ago

Interventions

Belumosudil 200 mg tabletdrug

Belumosudil 200 mg tablet, development candidate

[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdosedrug

test investigational medicinal product

[14C]-KD025 200 mg capsuledrug

test investigational medicinal product