Clinical trials: Mass Balance Study
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
Post-operative Nausea and Vomiting
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421
- Trial name
- NCT02881840
- Testing
- 14C-APD421
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
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
HIV Infections
Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants.
- Trial name
- NCT04507321
- Testing
- GSK3640254 Oral tablet, [14C]-GSK3640254 intravenous infusion, [14C]-GSK3640254 powder
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
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 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
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 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 Volunteers
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available…
- Trial name
- NCT04267276
- Testing
- Part 1: BI 1265162 - intravenous, Part 2: BI 1265162 - oral
- Where
- Netherlands
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
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 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 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
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
Non-Small Cell Lung Cancer, Metastatic Melanoma
A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
The aims of this Study were to determine: How much of the Study Drug (bemcentinib) ends up in urine and faeces How much of the Study Drug and its breakdown products get into the bloodstream The breakdown products (metabolites) of…
- Conditions
- Non-Small Cell Lung Cancer, Metastatic Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Trial name
- 8479217 (NCT06469138)
- Testing
- Bemcentinib
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BerGenBio ASA
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.
Opioid Use Disorder
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
The purpose of this open label study is to characterise the absorption, metabolism, excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male participants.
- Trial name
- NCT05974046
- Testing
- [14C]IDV184001AN
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral…
- Trial name
- NCT03811834
- Testing
- Mobocertinib
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.