Clinical trials: Mass Balance Study
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
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
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.
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
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.