Clinical trials: Mass Balance Study
Small Cell Lung Cancer, Solid Tumors
A Study of AL8326 in Healthy Subjects
This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard.
- Trial name
- NCT07132957
- Testing
- 14C-labeled AL8326
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Advenchen Laboratories Nanjing Ltd.
Healthy Male Volunteers
Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019
The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019
- Trial name
- NCT07479745
- Testing
- [14C]GRT6019
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Advanced Cancer
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy.
- Trial name
- NCT01583777
- Testing
- Belinostat
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- Acrotech Biopharma Inc.
Healthy
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
- Trial name
- NCT03448172
- Testing
- [14C]PF-05221304
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Myeloid Leukemia
TGRX-678 Pharmacokinetic Mass Balance
This is a pharmacokinetic study for [14C]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.
- Trial name
- NCT06986772
- Testing
- [14C]TGRX-678
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Pharmacokinetics
Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects
The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of…
- Trial name
- NCT02126956
- Testing
- ACT-128800
- Where
- Switzerland
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Actelion
Asthma
An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604
The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing…
- Trial name
- NCT06157255
- Testing
- AZD4604 Inhalation Powder, 1 mg, [14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL), [14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Atopic Dermatitis
The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]VC005 orally in Chinese healthy male volunteers.
- Trial name
- NCT06974292
- Testing
- [14C]VC005
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Healthy Volunteers
Study on the Mass Balance of [14C] CMS-D002 in Healthy Adult Participants in China
This phase 1, single-group study will evaluate the mass balance of [14C] CMS-D002 after a single oral dose in healthy adult participants in China.
- Trial name
- NCT07788482
- Testing
- [14C] CMS-D002
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
Healthy Male Subjects
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] SKLB1028.
- Trial name
- NCT05369858
- Testing
- [14C] SKLB1028
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer, Nonsmall Cell Lung Cancer
A Study of [14C]GB491 in Male Healthy Subjects
This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.
- Trial name
- NCT05860582
- Testing
- [14C]GB491
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
Relapsing-remitting Multiple Sclerosis
Mass Balance Study of MT-1303
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.
- Trial name
- NCT02293967
- Testing
- MT-1303
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Cardiovascular Diseases
Absorption, Distribution, Metabolism and Excretion of [14C] Labelled BIA 5-1058
The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling…
- Trial name
- NCT04069130
- Testing
- 400 mg of BIA 5-1058
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
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.
Advanced Solid Tumors
Single Dose Study of [14C]-Labelled AMG 706 in Patients With Advanced Solid Tumors
In order for a tumour to grow and spread to other parts of the body, it needs to have a blood supply. Certain proteins in the body, called cytokines or growth factors, have been shown to cause the growth of new blood vessels that…
- Trial name
- NCT01386866
- Testing
- AMG 706
- Volunteers
- 4 people
- Sponsor
- Amgen
Mass Balance Study
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; To obtain radioactive…
- Trial name
- NCT06233916
- Testing
- [14C] D-1553
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Healthy
A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose.
- Trial name
- NCT06572111
- Testing
- BI 1839100 (C-14) formulation 1, BI 1839100, BI 1839100 (C-14) formulation 2
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants.
- Trial name
- NCT04507321
- Testing
- GSK3640254 Oral tablet, [14C]-GSK3640254 intravenous infusion, [14C]-GSK3640254 powder
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Solid Tumors
An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors
The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.
- Trial name
- NCT05976334
- Testing
- [14C] Subasumstat, Subasumstat
- Where
- 2 sites in Hungary
- Volunteers
- 3 people
- Sponsor
- Takeda
Healthy
Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects
The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.
- Trial name
- NCT00550212
- Testing
- neratinib
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.