Clinical trials: BALANCE
Healthy Volunteer
Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
- Trial name
- NCT06425003
- Testing
- [14C] ABBV-CLS-7262
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Calico Life Sciences LLC
Type2 Diabetes Mellitus
Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets of Humanis, Turkey and Jardiance (Empagliflozin)…
- Trial name
- NCT06180109
- Testing
- Empagliflozin film coated tablets, Jardiance film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142.
- Trial name
- NCT07463053
- Testing
- [14C]JMKX003142, JMKX003142 tablets, [14C]JMKX003142 solution for infusion
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Jemincare
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral…
- Trial name
- NCT03811834
- Testing
- Mobocertinib
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Male Subjects
A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose
- Trial name
- NCT05621447
- Testing
- TAS-303, [14C]TAS-303
- Where
- Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Taiho 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.
Infections, Bacterial
Relative Bioavailability Study in Healthy Subjects
Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation.
- Trial name
- PDF112034 (NCT00924911)
- Testing
- GSK1322322
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
COVID-19
[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects
This trial adopts a single-center, single-dose, single-period, non-randomized, open-label study design. It is planned to enroll 6~8 healthy male subjects, and each subject receives single oral administration of drug solution…
- Trial name
- NCT05754411
- Testing
- [14C]STI-1558
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd.
Disorders of Sphingolipid Metabolism, Healthy Volunteers
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects
Primary Objectives: To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-venglustat.
- Trial name
- NCT05238714
- Testing
- venglustat
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Diabetes Mellitus, Diabetic Neuropathies
Smart Insoles for Improving Sensation, Balance and Mobility in People With Diabetic Peripheral Neuropathy.
The long-term effects of vibrating insoles on improving gait, balance and peripheral sensation in people with diabetic peripheral neuropathy remain unknown.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies, Unsteadiness
- Trial name
- Pathfeel (NCT06855420)
- Testing
- Vibration on, Vibration off
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Walk With Path
PMS, Menstrual Discomfort
Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome
This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.
- Conditions
- PMS, Menstrual Discomfort, Menstrual Pain
- Trial name
- NCT05237661
- Testing
- Moon Balance
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Your Super, INC.
Healthy
Enpatoran Human Mass Balance and Absolute Bioavailability Study
The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in…
- Trial name
- NCT05110027
- Testing
- Enpatoran, [14C]enpatoran microtracer, [14C]enpatoran microdose
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects
This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-NT-814 in healthy male subjects.
- Trial name
- NCT04654897
- Testing
- [14C]-NT-814
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
- Trial name
- NCT05101369
- Testing
- INCB086550
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Diabetes, Healthy
Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
- Trial name
- NCT01698697
- Testing
- insulin aspart
- Where
- South Africa
- Volunteers
- 24 people
- Sponsor
- Novo Nordisk A/S
Short Bowel Syndrome
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
- Trial name
- STARSnutrition (NCT04964986)
- Testing
- Apraglutide
- Where
- 2 sites in Belgium, France
- Volunteers
- 10 people
- Sponsor
- VectivBio AG
Healthy
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
- Trial name
- NCT01380561
- Testing
- asimadoline
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Tioga Pharmaceuticals
Healthy
Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK31679 in Healthy Adult Male Volunteers.
This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31679 in healthy male subjects.
- Trial name
- NCT06258746
- Testing
- [14C]HSK31679
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
Aging, Balance Deficits
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
The goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems.
- Trial name
- NCT06779188
- Testing
- Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Weinberg Medical Physics LLC
Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Lofexidine ADME & Mass Balance in Volunteers
The purpose of this study is to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine.
- Trial name
- NCT01310296
- Testing
- Lofexidine hydrochloride
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)