Clinical trials: Mass Balance Study
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.
Healthy Subjects
A Study to Evaluate Cenerimod in Healthy Male Subjects
The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air
- Trial name
- NCT02914223
- Testing
- Cenerimod
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Viatris Innovation GmbH
Healthy Subjects
A Study of [14C]IBI351 in Healthy Subjects
This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled.
- Trial name
- NCT05626179
- Testing
- [14C] IBI351
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
Healthy Female Participants
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
The purpose of this study is to evaluate the metabolism, the routes and extent of elimination, and drug levels of [14C]Navlimetostat (BMS-986504) in healthy female participants
- Trial name
- NCT07777133
- Testing
- Navlimetostat, [14C]Navlimetostat
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants
This study is conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-INCB161734 in healthy male participants.
- Trial name
- NCT07814404
- Testing
- INCB161734
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Healthy
Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.
- Trial name
- NCT04704739
- Testing
- GLPG1205 film-coated tablets, [14C]-GLPG1205 solution for infusion, GLPG1205 capsules
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Complement Mediated Primary or Secondary Glomerular Diseases
A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
- Trial name
- NCT06567392
- Testing
- [14C] HRS-5965
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Secondary Hypogonadism
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in…
- Trial name
- NCT02274181
- Testing
- Androxal
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Pruritus
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1405
The primary objectives of the study are: To assess the mass balance recovery after a single PO dose of [14C]-SK-1405 To provide plasma, urine and faecal samples for metabolite profiling and structural identification
- Trial name
- NCT02846181
- Testing
- [14C]-SK-1405
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.