Clinical trials: Impairment
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
HIV Infections
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients.
- Trial name
- NCT00435929
- Testing
- Ritonavir, saquinavir [Invirase]
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Healthy
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
- Trial name
- NCT02228395
- Testing
- PF-04958242
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Liver Dysfunction
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function
The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.
- Trial name
- NCT02005744
- Testing
- CKD-501
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Dyslipidemia
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
- Trial name
- NCT01122667
- Testing
- anacetrapib
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Type II Diabetes Mellitus, Renal Insufficiency
A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI0382 is well tolerated.
- Trial name
- NCT03550378
- Testing
- MEDI0382
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 41 people
- Sponsor
- MedImmune LLC
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hearing Loss, Hearing Impairment
Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption…
- Trial name
- Lexie (NCT06942325)
- Testing
- OTC self-fitting hearing aid, Prescription hearing aid
- Sponsor
- HearX SA
Infections, Bacterial
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required.
- Trial name
- NCT02729038
- Testing
- Gepotidacin
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Renal Impairment
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
- Trial name
- GLITTER (NCT06661733)
- Testing
- AZD5462
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Insufficiency
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function.
- Trial name
- NCT04933747
- Testing
- Iberdomide
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Impairment
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy…
- Trial name
- NCT04993157
- Testing
- FIA586
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Amnestic Mild Cognitive Impairment, Alzheimer's Disease
An Open-Label Study Investigating MK-8931 in Participants With Mild and Moderate Hepatic Insufficiency (MK-8931-016)
This study consists of Part I and an optional Part II. The purpose of Part I is to compare the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of 40 mg MK-8931 to participants with…
- Conditions
- Amnestic Mild Cognitive Impairment, Alzheimer's Disease, Prodromal Alzheimer's Disease
- Trial name
- NCT02910739
- Testing
- MK-8931
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Gout, Chronic Kidney Disease (CKD)
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
- Trial name
- NCT03226899
- Testing
- Lesinurad, XOI, colchicine
- Where
- 116 sites in United States, Czechia and 2 more
- Volunteers
- 242 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x…
- Trial name
- NCT03423446
- Testing
- Telotristat Ethyl
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Migraine
Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.
This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for…
- Trial name
- NCT05375097
- Testing
- Erenumab
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment.
- Trial name
- NCT00139620
- Testing
- Tarceva, erlotinib, OSI-774
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- OSI Pharmaceuticals
Blindness
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light…
- Trial name
- NCT04725760
- Testing
- BrainPort Vision Pro
- Where
- 7 sites in France
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Wicab
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