Clinical trials: Metabolism and Elimination
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.
Calcium Deficiency, Vitamin D Deficiency
Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases…
- Trial name
- Osteopro (NCT01639222)
- Testing
- Calcium 500 mg and Vitamin D3 800 IU, Low calcium meals
- Where
- Germany
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Takeda
Advanced Solid Tumors, Lymphomas
A Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients With Advanced Solid Tumors or Lymphomas, Who Are Unsuitable For, or Have Failed, Existing Therapies.
The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had failed, existing therapies.
- Trial name
- NCT02578316
- Testing
- Lenvatinib
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Eisai Inc.
Healthy
A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants
The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it and also to assess the pharmacokinetics (PK), metabolism, and routes and…
- Trial name
- NCT05630287
- Testing
- [14C]-Selpercatinib, Selpercatinib
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
Type 2 Diabetes
The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion
Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4 inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the mechanisms mediating the renal effects of DPP-4…
- Trial name
- INDORSE (NCT02406443)
- Testing
- Sitaglitpin
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- University Health Network, Toronto
Type 1 Diabetes
PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)
The purpose of this study is to determine if the early treatment with a blood pressure medication (an ACE Inhibitor) can prevent or delay the development of kidney disease (microalbuminuria) in patients with Type 1 diabetes who…
- Trial name
- PREVENTKD (NCT00729365)
- Testing
- Ramipril
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Northwestern University
Osteoporosis, Sarcopenia
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
There is increasing evidence that the acid-base balance of diet plays an important role in the health of bones and muscles. An excess of acid in the body can result in calcium loss and muscle breakdown.
- Trial name
- NCT00357214
- Testing
- Potassium Bicarbonate, Sodium Bicarbonate, Potassium Chloride
- Where
- United States
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Tufts University
Healthy
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers
The primary objective of this study is to characterize the metabolic disposition, pharmacokinetics (PK), and routes of elimination of [14C]-labeled BVD-523 after administration of a single, oral dose to healthy male subjects.
- Trial name
- NCT02994732
- Testing
- [14C]-BVD-523
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BioMed Valley Discoveries, Inc
Advanced Solid Tumors
A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.
- Trial name
- NCT00908908
- Testing
- eribulin
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Eisai 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
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.
Hypercholesterolemia, Coronary Heart Disease
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action.
- Trial name
- Phyteaux-III (NCT00863265)
- Testing
- Ezetimibe, Phytosterols + ezetimibe
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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
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.
Healthy
A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
The main objectives of this trial are: To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to…
- Trial name
- NCT06520553
- Testing
- BI 1569912 (C-14), BI 1569912 (C-13)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes Mellitus, Hypercalciuria
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes
- Trial name
- NCT03325114
- Testing
- Chlorthalidone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Rochester
Malignant Melanoma
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients…
- Trial name
- NCT01164891
- Testing
- RO5185426
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- Hoffmann-La Roche
Advanced Cancer
C14 Study in Oncology Patients With Advanced and/or Metastatic Solid Tumors
This is an open-label study being conducted to determine the metabolism and physiological disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or metastatic solid tumors.
- Trial name
- NCT01296568
- Testing
- LY2603618, Pemetrexed, Gemcitabine
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Eli Lilly and Company
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