Clinical trials: BALANCE
Healthy Volunteer
A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants
The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.
- Trial name
- NCT06953934
- Testing
- ABBV-932
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AbbVie
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.
Healthy Volunteer
Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.
The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products.
- Trial name
- NCT07141368
- Testing
- Curcumin Dispersome formulation, Non-formulated Curcumin, Benchmark Formulation 1 - Turmipure Gold™
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
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.
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.
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
A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)
The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.
- Trial name
- NCT06658626
- Testing
- [¹⁴C]Enlicitide chloride
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Cancer
A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of…
- Trial name
- NCT06302140
- Testing
- [14C]-Nanatinostat, Nanatinostat (free base) tablets in combination with Valganciclovir, Nanatinostat mesylate tablets in combination with Valganciclovir
- Where
- Spain
- Volunteers
- 8 people
- Sponsor
- Viracta Therapeutics, Inc.
Healthy
An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects
This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study in 6 healthy male subjects.
- Trial name
- NCT03446274
- Testing
- Evenamide
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Non-Small Cell Lung Cancer, Metastatic Melanoma
A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
The aims of this Study were to determine: How much of the Study Drug (bemcentinib) ends up in urine and faeces How much of the Study Drug and its breakdown products get into the bloodstream The breakdown products (metabolites) of…
- Conditions
- Non-Small Cell Lung Cancer, Metastatic Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Trial name
- 8479217 (NCT06469138)
- Testing
- Bemcentinib
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BerGenBio ASA
Psoriasis and Psoriatic Arthritis
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Trial name
- NCT06084663
- Testing
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Carcinoma, Non-Small-Cell Lung
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers
This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.
- Trial name
- NCT01034748
- Testing
- [14C]PF00299804
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Symbiotic & Colonization
The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates…
- Trial name
- NCT01983072
- Testing
- Infant formula, Breastfeeding
- Where
- 4 sites in France, Poland
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
- Trial name
- NCT01627847
- Testing
- Ropinirole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
- Trial name
- NCT01645449
- Testing
- Atorvastatin Calcium Tablets, 80 mg
- Where
- Germany
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Ulcers, Duodenal and Gastric
Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of ASA (Acetylsalicylic Acid) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fasting Conditions
An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fasting conditions.
- Trial name
- NCT01847404
- Testing
- Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one, Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two, ASA 100 mg tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Copanlisib Mass Balance Study
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
- Trial name
- NCT02119221
- Testing
- Copanlisib (BAY80-6946)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Subjects
A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body
The current study is designed to generate data for the investigation of absorption, distribution, metabolism and elimination (ADME) processes of pracinostat in humans, as well as generating samples for metabolite profiling and…
- Trial name
- NCT03495934
- Testing
- pracinostat
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Healthy Male Volunteers
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral…
- Trial name
- NCT05475834
- Testing
- SIM0417
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Fluid Balance
Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention.
- Trial name
- NCT06654557
- Testing
- 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only), 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D