Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025
NCT03907540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2022-05-26
Summary
Human, absorption, metabolism and excretion study of belumosudil (KD025)
Conditions
Interventions
- DRUG
-
Belumosudil 200 mg tablet
Belumosudil 200 mg tablet, development candidate
- DRUG
-
[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose
test investigational medicinal product
- DRUG
-
[14C]-KD025 200 mg capsule
test investigational medicinal product
Sponsors & Collaborators
-
Quotient Sciences
collaborator INDUSTRY -
Kadmon Corporation, LLC
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-05
- Primary Completion
- 2019-05-20
- Completion
- 2019-05-20
Countries
- United Kingdom
Study Locations
More Related Trials
-
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
NCT04454918 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers
NCT04150146 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration
NCT03040362 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
NCT06857695 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020
NCT02068053 ·Status: COMPLETED ·Phase: PHASE1
-
RE104 Radiolabeled Mass Balance (hAME) Study
NCT07146191 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
NCT05753592 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects
NCT05119790 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
NCT06433505 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
NCT04116476 ·Status: COMPLETED ·Phase: PHASE1
-
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
NCT03408470 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant
NCT02240290 ·Status: COMPLETED ·Phase: PHASE1
-
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
NCT01563562 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
NCT06687759 ·Status: COMPLETED ·Phase: PHASE1
-
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214
NCT01458899 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
NCT01503866 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of KUC 7483 Tablets in Healthy Male Volunteers
NCT02259907 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers
NCT02259842 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
NCT01012284 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
NCT02049528 ·Status: COMPLETED ·Phase: PHASE1
-
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
NCT04322253 ·Status: TERMINATED ·Phase: PHASE1
-
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
NCT06345950 ·Status: COMPLETED ·Phase: NA
-
Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
NCT01915771 ·Status: COMPLETED ·Phase: PHASE1
-
Absolute Bioavailability and ADME Study of [14C]AZD9977 in Healthy Male Subjects
NCT04686591 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
NCT04015076 ·Status: COMPLETED ·Phase: PHASE1