Clinical trials: Mass Balance Study
Healthy Subjects (HS)
A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males
This study aims to evaluate the absorption, metabolism, and excretion of a single oral dose of [¹⁴C]SSS17 in healthy adult Chinese male subjects, elucidating its overall pharmacokinetic profile in humans to provide essential…
- Trial name
- NCT07025915
- Testing
- [14C]SSS17
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Advanced Solid Tumors
Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI.
- Trial name
- NCT02031055
- Testing
- TAS-102 with a light tracer dose of [14C]FTD, TAS-102 with a light tracer dose of [14C] TPI, TAS-102 tablets
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Taiho Oncology, Inc.
Healthy Volunteers, Mass Balance Study
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
This study will be an open-label, non-randomized, absorption, metabolism, and excretion study to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of [14C]-AZD3293 and derived metabolites…
- Trial name
- AZD3293hADME (NCT02126514)
- Testing
- AZD3293
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
N/A, as Healthy Volunteers
Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant
The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken down and eliminated from the body. The compound to be administered will be radiolabeled.
- Trial name
- NCT02240290
- Testing
- tozadenant tablet, C14-tozadenant capsule
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Biotie Therapies Inc.
Healthy Volunteer
Mass Balance Study With MT-8554
This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 8554.
- Trial name
- MT-8554 MB (NCT03381404)
- Testing
- [14C] MT-8554
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma America, Inc.
Healthy Adult Subjects
A Study On Human Mass Balance And Biotransformation
This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male subjects.
- Trial name
- NCT05040113
- Testing
- CBP-307
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Connect Biopharm LLC
Fungal Infection
A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects…
- Trial name
- NCT04804059
- Testing
- [14C]-APX001 Oral Solution, [14C]-APX001 Solution for Infusion
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
The primary objectives of the study are: To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
- Trial name
- NCT03492996
- Testing
- LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LigaChem Biosciences, Inc.
Alzheimer's Disease
Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is…
- Trial name
- MB (NCT00777361)
- Testing
- AZD3480
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
Healthy Volunteers
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well…
- Trial name
- NCT04962724
- Testing
- Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution), Xevinapant 200 mg (Oral Solution)
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy
A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781
This is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via…
- Trial name
- NCT03131141
- Testing
- BC-3781
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nabriva Therapeutics AG
Asthma
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
AZD7594 is in clinical development for the treatment of asthma. This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite…
- Trial name
- NCT04002427
- Testing
- Intravenous Infusion, Inhaled dose
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumors, Lymphoma
Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB
This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.
- Trial name
- NCT01953783
- Testing
- IXAZOMIB
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Volunteers
A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall…
- Trial name
- NCT05103241
- Testing
- [14C] GP681
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Pain
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
The purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (TRA) and characterize the Pharmacokinetic (PK) of VX-993 after a single oral dose of 14C-VX-993.
- Trial name
- NCT06886269
- Testing
- 14C-VX-993
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Male Subjects
Mass Balance and Metabolism Study of 14C-Z-215
The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).
- Trial name
- NCT02618629
- Testing
- 14C-Z-215
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Zeria Pharmaceutical
Heathy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects.
- Trial name
- NCT03964558
- Testing
- [14C]-acebilustat solution
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Celtaxsys, Inc.
Healthy Volunteer
GSK1349572 Mass Balance Study
Mass balance study to determine the recovery of a single radiolabelled dose of GSK1349572 from urine and feces
- Trial name
- NCT00828763
- Testing
- [14c}-GSK1349572
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.