Clinical trials: Metabolism and Elimination
Chronic Hepatitis B
A Study to Evaluate the Mass Balance Absorption and AME of VBR
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
- Trial name
- NCT04637139
- Testing
- Vebicorvir (VBR)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Metabolic Processes
A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178
The study aims to assess the routes and the extent of metabolism and excretion of YM178 after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male volunteers.
- Trial name
- NCT01651312
- Testing
- 14C-labeled YM178
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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
Cancer
Study to Investigate the Absorption, Distribution, Metabolism and Elimination of [14C]GSK1120212
GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity currently being developed for the treatment of malignant melanoma.
- Trial name
- NCT01387204
- Testing
- GSK1120212
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Participants
The purpose of this study is to determine the absorption, metabolism, and excretion of [14C]-BGB-16673 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male…
- Trial name
- NCT06776679
- Testing
- [14C]-BGB-16673
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- BeiGene
Solid Tumours
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
- Trial name
- NCT01931761
- Testing
- [C14] selumetinib (oral)
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Male Volunteers
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
The purpose of this study is to evaluate the excretion pathway of orally administered [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
- Trial name
- NCT05981963
- Testing
- [14C]-BMS-986196
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants.
- Trial name
- NCT04493255
- Testing
- [14C]E7090
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Limited
Bacterial Enteritis
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
- Trial name
- NCT02440633
- Testing
- 14C-OPS-2071
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Solid Tumor
Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib
The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease…
- Trial name
- AME (NCT02986100)
- Testing
- C-14 labeled Rucaparib, Rucaparib
- Where
- Hungary
- Volunteers
- 6 people
- Sponsor
- pharmaand GmbH
Chronic Obstructive Pulmonary Disease (COPD)
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein [P-gp] and breast cancer resistance protein [BCRP] transporters) on CHF6001…
- Trial name
- DDI2 (NCT06892756)
- Testing
- CHF6001 dry powder inhaler (DPI), Cyclosporine, CHF6001 DPI
- Where
- Bulgaria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy
Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers
Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of drug that is recovered over time via different elimination routes of the body, i.e., whole blood, blood cells, plasma, urine, feces…
- Trial name
- NCT02142127
- Testing
- 14C-labelled GFT505 120 mg
- Where
- Belgium
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genfit
Healthy Volunteer
A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers
This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.
- Trial name
- NCT01631422
- Testing
- RO4602522
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan
This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation.
- Trial name
- NCT00009542
- Testing
- kava (Piper methysticum)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Advanced Solid Tumors
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors
This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C…
- Trial name
- NCT01299701
- Testing
- ASA404
- Where
- New Zealand
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants
Mass Balance Clinical Trial With TEV-56286
Mass balance clinical trial with TEV-56286
- Trial name
- NCT06627231
- Testing
- TEV-56286, [14C]-TEV-56286
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy
A Study of [14C]-LOXO-783 in Healthy Adult Participants
The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when…
- Trial name
- NCT06102512
- Testing
- [¹⁴C]-LOXO-783, LOXO-783
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284…
- Trial name
- NCT06786286
- Testing
- [14C]-ITI-1284
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.
Healthy Volunteers
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential
This is an open-label, single-center, two part study in healthy female subjects of non-childbearing potential to investigate the absorption, metabolism, and excretion of [14C]-GDC-9545 (Part 1), the absolute bioavailability of…
- Trial name
- NCT04680273
- Testing
- [14C]-GDC-9545, GDC-9545 Solution for Infusion, GDC-9545/F12 Capsule
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy Adults
A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants
The purpose of this study is to learn how the body processes the study medicine PF-07104091. The study is seeking participants who are: Healthy male aged 18 to 65 years of age Participants in the study will receive 14C-labeled…
- Trial name
- NCT07127770
- Testing
- PF-07104091
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Pfizer