Clinical trials: Mass Balance Study
Healthy
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
The main objective of this trial is to Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) Provide plasma and urine samples for pharmacokinetic…
- Trial name
- NCT05833035
- Testing
- BI 1291583 mixed with [C-14] BI 1291583
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Solid Tumor
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
- Trial name
- NCT03804515
- Testing
- 14C-labeled poziotinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Healthy Volunteer
A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
- Trial name
- NCT07219017
- Testing
- ABBV-1354
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy Volunteers
Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects
This is a phase 1, open-label, ADME study with single oral administration of [14C]-DZD9008 in healthy subjects.
- Trial name
- NCT05159895
- Testing
- [14C]-DZD9008
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Dizal Pharmaceuticals
Tumors
A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664)
The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and routes and extent of elimination of BMS-582664
- Trial name
- NCT00435669
- Testing
- Brivanib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Bristol-Myers Squibb
Sepsis, Septic Shock
OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
This study examines how well the Oxiris® hemofilter works over time in adults with septic shock who require continuous kidney support in the intensive care unit (ICU).
- Conditions
- Sepsis, Septic Shock, Blood Purification, Hemoadsorption
- Trial name
- OxiCLEAR (NCT07419802)
- Testing
- AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)
- Where
- Latvia
- Volunteers
- 29 people
- Sponsor
- Pauls Stradins Clinical University Hospital
Healthy Participants
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.
- Trial name
- NCT06309394
- Testing
- INCB099280
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Healthy Volunteers, Healthy
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy.
- Trial name
- NCT03163173
- Testing
- GC4419
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Galera Therapeutics, Inc.
Healthy Participants
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth.
- Trial name
- NCT07812077
- Testing
- [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, [14C]AZD4954 Solution for Infusion
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Adult Male Volunteers
Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR1459 in Healthy Adult Male Volunteers
Evaluate the Mass Balance and Biotransformation of [14C]SHR1459 in Healthy Adult Male Volunteers
- Trial name
- NCT05095337
- Testing
- [14C]SHR1459
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sickle Cell Disease
A GBT021601 ADME Microtracer Study in Healthy Volunteers
An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
- Trial name
- NCT05718687
- Testing
- GBT021601
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500…
- Trial name
- NCT04234672
- Testing
- TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy Male Subjects
Mass Balance Study of FYU-981
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
- Trial name
- NCT02901366
- Testing
- 14C-FYU-981
- Where
- Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Fuji Yakuhin Co., Ltd.
Healthy
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following…
- Trial name
- NCT02205905
- Testing
- 14C PER977
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Infection, Human Immunodeficiency Virus
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects
This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations.
- Trial name
- NCT01273103
- Testing
- 200mg [14C]- GSK2248761
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Enpatoran Human Mass Balance and Absolute Bioavailability Study
The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in…
- Trial name
- NCT05110027
- Testing
- Enpatoran, [14C]enpatoran microtracer, [14C]enpatoran microdose
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately…
- Trial name
- NCT01756768
- Testing
- [14C]-PD-0332991
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Malaria
Human Mass Balance Study of Pyronaridine
The combination of pyronaridine and artesunate is an antimalarial therapy in development. This mass balance study is intended to determine the rate and extent of excretion of total radioactivity in urine and feces following…
- Trial name
- NCT01383109
- Testing
- 14C-labeled Pyronaridine
- Where
- Switzerland
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
- Trial name
- NCT06699628
- Testing
- IRL757
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Integrative Research Laboratories AB