Clinical trials: Mass Balance Study
Type 2 Diabetes
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance…
- Trial name
- NCT02353975
- Testing
- SHR3824
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anaemia
Absorption and Elimination of Radiolabeled Daprodustat
Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in previous clinical trials; however, the elimination routes and metabolic pathways of daprodustat have not been fully elucidated in humans.
- Trial name
- NCT03239522
- Testing
- [14C]-GSK1278863 solution for IV infusion, [14C]-GSK1278863 oral solution, Daprodustat 6 mg oral tablet
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Community-acquired Infection
GSK2251052 Mass Balance in Healthy Adult Subjects
Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions.
- Trial name
- NCT01475695
- Testing
- 14C GSK2251052
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants
A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants
The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity…
- Trial name
- NCT06301971
- Testing
- Emraclidine
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Healthy
A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants
The study has two parts, Part A and Part B. The purpose of Part A is to determine the absorption, metabolism, and excretion (AME) of [14C]-LY4100511 and to characterize and determine the metabolites present in plasma, urine, and…
- Trial name
- NCT06627088
- Testing
- LY4100511 (DC-853), [14C]-LY4100511 (DC-853) Administered oral dose, [14C]-LY4100511 (DC-853)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Healthy
A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body
Part A - the primary objective is to assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.
- Trial name
- NCT05879991
- Testing
- zongertinib (C-14), zongertinib
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777
The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.
- Trial name
- NCT04931524
- Testing
- carbon-14-[14C]-ANG-3777
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Angion Biomedica Corp
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
- Trial name
- NCT06004960
- Testing
- [14C]CCX168
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
To assess the mass balance recovery after a single oral dose of 14C-AB1010
- Trial name
- NCT05200169
- Testing
- 14C-AB1010
- Where
- United Kingdom
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- AB Science
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
Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers
This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in the United States (USA). This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance…
- Trial name
- NCT03775668
- Testing
- 1 µCi of 14C-AAI101 + 500 mg AAI101
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Allecra
Healthy
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants.
- Trial name
- NCT06777602
- Testing
- [14C] MK-5475
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pain
Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
- Trial name
- NCT00829088
- Testing
- AZD2066
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
14C-ARN-509 Microtracer Label AME and Absolute BA Study
This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
- Trial name
- NCT01822041
- Testing
- ARN-509
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aragon Pharmaceuticals, Inc.
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 Participants
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.
This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled [14C]PF-07321332 in healthy male participants following oral administration with…
- Trial name
- NCT05178654
- Testing
- [14C]PF-07321332
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Mass Balance Study
Mass Balance Study of [14C] D-2570
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body.
- Trial name
- NCT07411742
- Testing
- [14C] D-2570 group
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Anesthesia, Sedation
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous [14C]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and…
- Trial name
- NCT03751969
- Testing
- HSK3486
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy Volunteer
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male…
- Trial name
- NCT04655898
- Testing
- [14C]CC-90001
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Celgene
ADME, Healthy
A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
- Trial name
- NCT03525405
- Testing
- napabucasin
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sumitomo Pharma America, Inc.