Clinical trials: Mass Balance Study
Clinical Trial, Phase I, Pharmacokinetics
Rogaratinib (BAY1163877) Human Mass Balance Study
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution.
- Trial name
- NCT03484585
- Testing
- Rogaratinib (BAY1163877)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects
A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.
- Trial name
- ARIADME (NCT02418650)
- Testing
- ODM-201 300 mg tablet, intravenous14C-ODM-201, 300 mg 14C-ODM-201 oral solution
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
Food Effect and Mass Balance Study of XZP-3621 Tablets
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects.
- Trial name
- NCT05034120
- Testing
- XZP-3621
- Where
- China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
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
Healthy
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
- Trial name
- NCT03067376
- Testing
- [14C]-CORT125134
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
Type 2 Diabetes Mellitus, Weight Loss
A Clinical Study of Mass Balance of [14C]HRS-7535
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.
- Trial name
- NCT06819488
- Testing
- [14C]HRS-7535
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
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 Participants
A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
This study in healthy volunteers aims to answer these questions: Does the test medicine cause any important side effects? What are the blood levels of the test medicine and how quickly does the body get rid of it? How much of the…
- Trial name
- NCT06857695
- Testing
- AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion, [14C]AZD5004 Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Small Cell Lung Cancer
Mass Balance Study of [14C]Chiauranib
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
- Trial name
- NCT05371899
- Testing
- Chiauranib
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Healthy Subjects
Mass Balance Study of ASP1941
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.
- Trial name
- NCT01302132
- Testing
- ASP1941
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Solid Tumor
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)
This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and…
- Trial name
- NCT06308263
- Testing
- Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib, Tuvusertib + [14C]Tuvusertib microdose bolus injection
- Where
- Hungary
- Volunteers
- 12 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ADHD, Fibromyalgia
TD-9855 Mass Balance Study
The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
- Trial name
- NCT01924143
- Testing
- TD-9855
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
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.