Clinical trials: Mass Balance
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Mass Balance Study
A Mass Balance Study on [14C]Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects
To quantitatively analyze the total radioactivity in excreta from healthy male subjects following a single intravenous infusion of [14C]levornidazole disodium phosphate, and to semi-quantitatively estimate the recovery of 14CO₂…
- Trial name
- NCT07906197
- Testing
- Levornidazole Disodium Phosphate for Injection
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
Advanced Solid Tumors, Lymphoma
Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB
This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.
- Trial name
- NCT01953783
- Testing
- IXAZOMIB
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers
This study will look at the relative amounts of GSK189075 that are found in samples of blood, urine, and feces of healthy male volunteers.
- Trial name
- NCT00501683
- Testing
- Radiolabelled GSK189075
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Postoperative Ileus
A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101
A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.
- Trial name
- NCT01668199
- Testing
- TZP-101
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Norgine
Solid Tumor
A Phase 1 TH-302 Mass Balance Trial
This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer…
- Trial name
- NCT02076230
- Testing
- [14C] TH-302 (Label 1), [14C] TH-302 (Label 2), Unlabeled TH-302
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects
This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-orvepitant in healthy male subjects.
- Trial name
- NCT04387981
- Testing
- [14C]-orvepitant
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Nerre Therapeutics Ltd.
Healthy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
This single-center, open-label, non randomized Phase I study is being conducted to investigate the pharmacokinetics, mass balance and metabolite profiling and identification after a single oral dose of 100mg of [14C]-MD1003 in 6…
- Trial name
- NCT04223232
- Testing
- [14C]-MD1003
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Chronic Kidney Diseases
A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects
The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]HRS-1780 following an oral single dose in healthy adult male participants.
- Trial name
- NCT07557407
- Testing
- [14C]HRS-1780
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy Volunteer Study
Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)
Mass balance study of AT-527 in Healthy Male Subjects.
- Trial name
- NCT05004415
- Testing
- AT-527 (R07496998)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Healthy Volunteers
Copanlisib Mass Balance Study
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
- Trial name
- NCT02119221
- Testing
- Copanlisib (BAY80-6946)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Pharmacokinetics
Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male participants, revealing the overall…
- Trial name
- NCT05873426
- Testing
- [14C] ZSP1273
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Clinical Trial, Phase I, Pharmacokinetics
Rogaratinib (BAY1163877) Human Mass Balance Study
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution.
- Trial name
- NCT03484585
- Testing
- Rogaratinib (BAY1163877)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Participant Study
RE104 Radiolabeled Mass Balance (hAME) Study
The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers.
- Trial name
- NCT07146191
- Testing
- 2-[14C]-RE104 for Injection
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Reunion Neuroscience Inc
Healthy Subjects
Single Dose Study To Study The Absorption, Metabolism And Excretion Of Famitinib
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of famitinib in healthy adult male subjects.
- Trial name
- NCT05473468
- Testing
- Famitinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Health Volunteers
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.
- Trial name
- NCT01765855
- Testing
- Betrixaban single oral dose
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
- Trial name
- NCT01380561
- Testing
- asimadoline
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Tioga Pharmaceuticals
Hemodialysis Subjects With Secondary Hyperparathyroidism
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
- Trial name
- NCT07284043
- Testing
- [14C] MT1013/MT1013 Injection
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Lofexidine ADME & Mass Balance in Volunteers
The purpose of this study is to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine.
- Trial name
- NCT01310296
- Testing
- Lofexidine hydrochloride
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Type 2 Diabetes Mellitus, Weight Loss
A Clinical Study of Mass Balance of [14C]HRS-7535
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.
- Trial name
- NCT06819488
- Testing
- [14C]HRS-7535
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.