Clinical trials: Balance Assessment
Healthy Volunteers
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available…
- Trial name
- NCT04267276
- Testing
- Part 1: BI 1265162 - intravenous, Part 2: BI 1265162 - oral
- Where
- Netherlands
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Participants
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants. The study is seeking for participants who: are males aged 18 to 65 years and are healthy.
- Trial name
- NCT06267963
- Testing
- Oral [14C]PF-07220060, Oral PF-07220060, IV [14C] PF-07220060
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Obstructive Pulmonary Disease (COPD), COPD
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male…
- Trial name
- NCT04756960
- Testing
- CHF6001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Correction of Moderate to Severe Nasolabial Folds
Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.
- Trial name
- NCT03319719
- Testing
- Belotero® Balance with integral lidocaine, Belotero® Balance
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Merz North America, Inc.
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.
Healthy
Copper Balance in Healthy Participants Administered ALXN1840
The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.
- Trial name
- NCT04594252
- Testing
- ALXN1840
- Where
- United Kingdom
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Dry Eye
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
- Trial name
- NCT02776670
- Testing
- Propylene glycol, 0.6% eye drops, Lubricant eye drops
- Volunteers
- 308 people
- Sponsor
- Alcon Research
Cystic Fibrosis
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic…
- Trial name
- NCT04059094
- Testing
- BI 1265162
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Correction of Volume Loss in the Infraorbital Hollow Area
A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
- Trial name
- NCT03777917
- Testing
- Belotero Balance®
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Merz North America, Inc.
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500…
- Trial name
- NCT04234672
- Testing
- TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
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.
Advanced Solid Tumors, Neoplasms, Advanced Solid
A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
The purpose of this study is to assess the mass balance (that is, cumulative excretion of total radioactivity [TRA] in urine and feces) and to characterize the pharmacokinetics (PK) of pevonedistat in whole blood, plasma, and…
- Trial name
- NCT03057366
- Testing
- Pevonedistat, [14C]-Pevonedistat, Docetaxel
- Where
- 2 sites in Hungary
- Volunteers
- 8 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Adult Male
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess…
- Trial name
- NCT04182958
- Testing
- (14C)-OPC-61815
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Dry Eye Syndrome, Lipid Deficiency
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
- Trial name
- NCT01688726
- Testing
- SYSTANE® BALANCE eyedrops, Minims® Saline 0.9% eyedrops
- Volunteers
- 91 people
- Sponsor
- Alcon Research
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
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 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.
PMS, Menstrual Pain
Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
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.
- Trial name
- NCT05145257
- Testing
- Elix Cycle Balance
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Zenchi, Inc.
Musculoskeletal Diseases
Medacta NextAR TKA Pivotal Trial
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
- Trial name
- NCT04844879
- Testing
- NextAR TKA system
- Where
- 4 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Medacta International SA
Psychosocial Deprivation, Work-Related Stress
Family Supportive Supervisor Training and Workplace Assessment Tool
This study will evaluate the effectiveness of FSST 2.0 (family supportive supervisor training plus support for use of family and sick leaves) using a randomized control trial design.
- Conditions
- Psychosocial Deprivation, Work-Related Stress, Life-work Imbalance
- Trial name
- FSST (NCT05080426)
- Testing
- Family Supportive Supervisor Training 2.0
- Where
- United States
- Volunteers
- 1,175 people, healthy volunteers welcome
- Sponsor
- Work Life Help