Clinical trials: Metabolism and Elimination
Pulmonary Arterial Hypertension
Absorption, Distribution, Metabolism and Excretion of BIA 5-1058
the purpose of this study is: to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7…
- Trial name
- ADME (NCT04991181)
- Testing
- 400 mg BIA 5-1058
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hepatic Insufficiency, Liver Diseases
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
- Conditions
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism
- Trial name
- NCT07102095
- Testing
- Sevabertinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Participants
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth.
- Trial name
- NCT07812077
- Testing
- [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, [14C]AZD4954 Solution for Infusion
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Metabolism and Excretion of [14C]-Rigosertib After Infusion to Volunteers
The purpose of this study is to gain an understanding of how the experimental anti-cancer drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is given as an intravenous infusion.
- Trial name
- NCT02030639
- Testing
- rigosertib
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Traws Pharma, Inc.
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
Neoplasm
Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib
This is an open-label, two-part study in participants with solid tumours and will be conducted at multiple study sites. Participants will be assessed for study eligibility prior to admission to the study site.
- Trial name
- NCT06754761
- Testing
- [14C] AZD6738, AZD6738 / ceralasertib
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- AstraZeneca
Healthy
Study of Radiolabeled ALXN2050 in Healthy Adult Males
This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
- Trial name
- NCT04609670
- Testing
- [14C]-ALXN2050
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Advanced Solid Tumor
The Absorption, Metabolism and Excretion of [14C]CM082 in Human
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] CM082 in healthy Chinese male subjects.
- Trial name
- NCT04434326
- Testing
- [14]CM082 suspension
- Where
- China
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- AnewPharma
Healthy Participants
A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants
The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity…
- Trial name
- NCT06301971
- Testing
- Emraclidine
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Leukopenia
To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers
- Trial name
- NCT04283695
- Testing
- GX-I7 or [14C] GX-I7
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Healthy
A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single…
- Trial name
- NCT06325930
- Testing
- [14C]-HU6
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Rivus Pharmaceuticals, Inc.
HCV
Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.
- Trial name
- NCT00823745
- Testing
- [14C]-PF-00868554
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Pfizer
Familial Hypercholesterolemia
Soy Food Intervention Trial
Familial hypercholesterolemia (FH MIM#143890), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD).
- Trial name
- SOYFIT (NCT00924339)
- Testing
- soy protein diet, rapeseed oil
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Medical University of Vienna
Dementias With Lewy Bodies
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
The primary objective of the study is to achieve mass balance recovery of [14C]-radiolabel in urine and feces and to identify and quantify the main elimination pathways of E2027.
- Trial name
- NCT04023877
- Testing
- E2027
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Respiratory Syncytial Virus Infections
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir). This study is looking for healthy adult participants who meet the following criteria: 1.
- Trial name
- NCT05873764
- Testing
- 200 mg RV521/78 µCi [ 14C]-RV521.
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Healthy Volunteers
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants.
- Trial name
- NCT05847439
- Testing
- [14C]BMS-986419
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.
- Trial name
- NCT02504463
- Testing
- Samidorphan IV, [14c]-Samidorphan sublingual, [14c]-Samidorphan oral
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Healthy Volunteers
A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants
This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and…
- Trial name
- NCT04560738
- Testing
- [14C]-CC-92480
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Celgene
Pain
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
- Trial name
- NCT00832169
- Testing
- AZD1386
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca