Clinical trials: Metabolism and Elimination
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 Subjects, Pharmacokinetics of MDV3100
A Study to Explore the Routes of Elimination of MDV3100
A study to investigate the excretion routes of radio-labelled MDV3100.
- Trial name
- NCT01911715
- Testing
- MDV3100
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy
A Study in Healthy Men to Test How BI 1815368 is Processed in the Body
The main objectives are: To assess mass balance by determining the extent of recovery of total [¹⁴C]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy…
- Trial name
- NCT07693218
- Testing
- BI 1815368 (C-14), BI 1815368 (C-13)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19.
- Trial name
- NCT05580003
- Testing
- PF-07817883, Midazolam, Moxifloxacin
- Where
- 2 sites in United States, Belgium
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Pfizer
Coronary Artery Disease
Study of [3H] BMS747158 in Healthy Male Subjects
The purpose of this clinical study is to assess the safety, extent and route of [3H] BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male subjects.
- Trial name
- PPA103 (NCT00930631)
- Testing
- [3H] BMS747158
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Lantheus Medical Imaging
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
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
- Trial name
- NCT06004960
- Testing
- [14C]CCX168
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Subjects
A Phase I, Open-label Study of Absorption, Metabolism, and Excretion of Defactinib (VS-6063) in Healthy Male Subjects
This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of defactinib.
- Trial name
- NCT02913716
- Testing
- defactinib
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Verastem, Inc.
Obesity
The Effects of Dairy Products on Energy Balance
The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately…
- Trial name
- MEPEB (NCT01199835)
- Testing
- High Calcium intake from dairy products
- Where
- Denmark
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Obesity, Gallstones
Obeticholic Acid in Bariatric and Gallstone Disease
By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals.
- Trial name
- OCABSGS (NCT01625026)
- Testing
- Obeticholic acid
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Sahlgrenska University Hospital
Syndrome of Inappropriate Antidiuresis (SIAD)
Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIAD
This study aims to investigate whether a 7-day dietary high protein supplementation of 90 grams per day increases plasma sodium levels in hyponatremic patients with chronic SIAD.
- Trial name
- TREASURE (NCT04987385)
- Testing
- Protein supplementation, Oral urea
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- University Hospital, Basel, Switzerland
Solid Malignancies
Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase
This Phase 1, open label, single centre, non-randomised study in patients with advanced solid malignancies consists of two parts: 1.
- Trial name
- 14C (NCT02640755)
- Testing
- [14C]AZD2014, Multiple dose AZD2014, Fulvestrant
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Healthy
Absorption, Metabolism, Excretion and Absolute Bioavailability
This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans.
- Trial name
- NCT03250039
- Testing
- PF-04965842, Absolute Bioavailability
- Where
- 2 sites in Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subject
Human Mass Balance Study of HMS5552 in Healthy Subjects
This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of [14C]-HMS5552.
- Trial name
- NCT03158506
- Testing
- HMS5552
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hua Medicine Limited
Bioequivalence Trial
Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules
This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time…
- Trial name
- NCT06307132
- Testing
- Aximus capsules（test）, Aximus capsules（reference）
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Healthy
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of [14C] Fruquintinib
This will be an open-label, single-center study to evaluate pharmacokinetics and safety of HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of HMPL-013 containing approximately 100 microcuries of…
- Trial name
- NCT02689752
- Testing
- fruquintinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Asthma
An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604
The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing…
- Trial name
- NCT06157255
- Testing
- AZD4604 Inhalation Powder, 1 mg, [14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL), [14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Thalassemia, Iron Overload
Oral Nifedipine to Treat Iron Overload
This study will determine if nifedipine, a medication used to treat high blood pressure, can help treat iron overload, a condition in which the body contains too much iron.
- Conditions
- Thalassemia, Iron Overload, Hemochromatosis
- Trial name
- NCT00712738
- Testing
- Nifedipine, Phlebotomy, Urinalysis
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Healthy Volunteers
A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants
The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of…
- Trial name
- NCT05607537
- Testing
- E7386 Tablet, (14C)E7386 Capsule, (14C)E7386
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eisai Limited
Healthy Participants
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants.
- Trial name
- NCT06645704
- Testing
- EP262
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc