Clinical trials: Mass Balance Study
Advanced Solid Tumor
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was to provide a quantitative characterization of the mass balance, rates and routes of elimination…
- Trial name
- NCT05246111
- Testing
- [14C]Berzosertib, Berzosertib, Topotecan
- Where
- 2 sites in Hungary
- Volunteers
- 6 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy Volunteers
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.
- Trial name
- NCT04729309
- Testing
- [12C] RO7049389, [13C] RO7049389, [14C] RO7049389
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Healthy Participants
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants. The study is seeking for participants who: are males aged 18 to 65 years and are healthy.
- Trial name
- NCT06267963
- Testing
- Oral [14C]PF-07220060, Oral PF-07220060, IV [14C] PF-07220060
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803
The purpose of this study is to assess the pharmacokinetics, excretion, mass balance and metabolism of PF-07265803 (formerly known as ARRY-371797) in approximately 6 healthy adult male participants.
- Trial name
- NCT05286281
- Testing
- PF-07265803
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alzheimer Disease
Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812
- Trial name
- COG0108 (NCT05225389)
- Testing
- 300 mg [C14] CT1812
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cognition Therapeutics
Healthy Volunteers
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled…
- Trial name
- NCT02252354
- Testing
- [14C]-TAK-385 Oral Solution, TAK-385 Tablets, [14C]-TAK-385 Solution for Intravenous Infusion
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in healthy male volunteers
- Trial name
- NCT02096679
- Testing
- AZD9291
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Autoimmune Diseases, Fibrosis
Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025
Human, absorption, metabolism and excretion study of belumosudil (KD025)
- Trial name
- KD025-108 (NCT03907540)
- Testing
- Belumosudil 200 mg tablet, [14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose, [14C]-KD025 200 mg capsule
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Kadmon Corporation, LLC
Healthy Volunteers
Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104.
- Trial name
- NCT01299285
- Testing
- LY3009104
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a…
- Trial name
- NCT04992442
- Testing
- TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites.
- Trial name
- NCT03500224
- Testing
- [14C]-TAK-954
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
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.
Healthy Volunteers
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg)…
- Trial name
- NCT04454918
- Testing
- TAK-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion, [14C]-TAK-906 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understanding of human…
- Trial name
- NCT05050682
- Testing
- PF-07304814
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
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
Healthy Participants
A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men
The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up and processed by healthy male participants. The study consists of two parts, called study periods.
- Trial name
- NCT05652647
- Testing
- Oral [14C]PF-07081532, Oral PF-07081532 and IV [14C]PF-07081532
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer