Clinical trials: Mass Balance Study
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
Type 2 Diabetes
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes.
- Trial name
- NCT00912002
- Testing
- MK-0941
- Volunteers
- 6 people
- 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.
Normal Healthy Volunteers
Lofexidine Mass Balance in Volunteers
The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body.
- Trial name
- NCT01629446
- Testing
- Lofexidine hydrochloride
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Cancer
A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer
This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer
- Trial name
- NCT01023386
- Testing
- YM155
- Where
- Hungary
- Volunteers
- 6 people
- Sponsor
- Astellas Pharma Inc
Helicobacter Pylori Infection
Human Mass Balance and Biotransformation Study of [14C]TNP-2198
The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants
- Trial name
- NCT06137573
- Testing
- [14C]TNP-2198
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Healthy Male Adult
The Mass Balance and Biotransformation of [14C] Vicagrel in Healthy Man
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Vicagrel orally in Chinese healthy male volunteers, revealing the overall pharmacokinetic characteristics of vicagrel in humans…
- Trial name
- NCT04143750
- Testing
- [14C]Vicagrel
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Chronic Hepatitis B-related Liver Fibrosis
[¹⁴C] Hydronidone Mass Balance Study
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it…
- Trial name
- NCT07471217
- Testing
- [¹⁴C]Hydronidone
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Healthy Male Subjects
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics…
- Trial name
- NCT05072028
- Testing
- [14C]DBPR108
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Invasive Fungal Infections
Absorption, Metabolism and Excretion of 14C-olorofim in Man
Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6…
- Trial name
- hAME (NCT04039880)
- Testing
- Olorofim
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Healthy Volunteers
Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants
The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of [14C]-DC-806 in urine and feces.
- Trial name
- NCT06045000
- Testing
- DC-806, [14C]-DC-806
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
- Trial name
- NCT06852092
- Testing
- Carbon-14 labeled HSK39297
- Where
- China
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Pharmacokinetics of 14C-labeled Isavuconazole, Healthy Subjects
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
- Trial name
- NCT01813461
- Testing
- 14C-labeled prodrug isavuconazonium sulfate
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.