Clinical trials: Impairment
Hepatitis C Virus
TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435.
- Trial name
- NCT01046058
- Testing
- TMC435
- Where
- 3 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatic Impairment, Healthy Volunteers
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.
- Trial name
- NCT03824678
- Testing
- CC-220
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celgene
Mild Cognitive Impairment
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
- Trial name
- NCT06347315
- Testing
- BrainXpert
- Where
- 28 sites in France, Germany and 4 more
- Volunteers
- 380 people
- Sponsor
- Société des Produits Nestlé (SPN)
Gout
Mild, Moderate and Severe Renal Impairment Study
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
- Trial name
- NCT02219516
- Testing
- RDEA3170
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Ardea Biosciences, Inc.
Liver Dysfunction, Healthy
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild…
- Trial name
- NCT06916078
- Testing
- Lepodisiran
- Where
- 4 sites in United States, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment, Healthy
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of…
- Trial name
- NCT02647918
- Testing
- Sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Renal Insufficiency
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam.
- Trial name
- NCT04486625
- Testing
- Aztreonam-Avibactam
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alzheimer Disease, Dementia
Reducing Dementia Risk With Digital Health Coaching
The Digital Cognitive Multi-domain Alzheimer's Risk Velocity (DC MARVEL) study is a 2-year randomized controlled trial on dementia prevention.
- Conditions
- Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Decline
- Trial name
- DC-MARVEL (NCT04559789)
- Testing
- MindMate + Health Coaching, Health Education
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Neurotrack Technologies, Inc.
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Fabry Disease
A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
- Trial name
- NCT04020055
- Testing
- migalastat HCl 150 mg
- Where
- 12 sites in United States, Australia and 4 more
- Volunteers
- 14 people
- Sponsor
- Amicus Therapeutics
Kidney Failure, Chronic, End-Stage Kidney Disease
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time.
- Conditions
- Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage
- Trial name
- NCT06814132
- Testing
- MK-5684, Prednisone, Fludrocortisone acetate
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension, Impaired Glucose Tolerance
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate…
- Trial name
- NCT00847899
- Testing
- AR9281
- Where
- 30 sites in United States
- Volunteers
- 150 people
- Sponsor
- Arete Therapeutics
Prevention of Thromboembolic Events
Study to Assess the Safety, Tolerability, Effects on the Body, Absorption, Distribution and Elimination of 25 mg BAY2433334 in Renal Impairment Including Renal Replacement Therapy ("Dialysis")
BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the…
- Trial name
- NCT04510987
- Testing
- BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5, BAY2433334 on dialysis treatment day
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Bayer
Known or Suspected Focal Liver Lesions, Severe Renal Impairment
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment.
- Trial name
- SPARKLE (NCT04119843)
- Testing
- Mangoral
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 87 people
- Sponsor
- Ascelia Pharma AB
Alzheimer Disease, Mild Cognitive Impairment
A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
The purpose of this study is to learn about health care use, costs, and clinical outcomes over time for amyloid positive participants with early stages of AD in the United States.
- Trial name
- GERAS-US (NCT02951598)
- Testing
- Florbetapir F 18 PET Scan
- Where
- 77 sites in United States
- Volunteers
- 1,400 people
- Sponsor
- Eli Lilly and Company
Healthy, Liver Diseases
A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems
This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.
- Trial name
- NCT06272058
- Testing
- Avenciguat (BI 685509)
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cognitive Impairment, Alzheimer Disease
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination of donepezil and mefloquine to improve cognitive function in healthy male volunteers after impairment by a scopolamine challenge.
- Trial name
- NCT03698695
- Testing
- THN 201, Donepezil
- Where
- 7 sites in France
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Theranexus
Healthy Volunteer
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.
- Trial name
- NCT01510899
- Testing
- RO4917838
- Where
- 3 sites in France, Russia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.
- Trial name
- NCT01565902
- Testing
- BAF312
- Where
- 3 sites in Hungary, Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
- Trial name
- NCT00847301
- Where
- 53 sites in Austria, France and 5 more
- Volunteers
- 472 people
- Sponsor
- Boehringer Ingelheim
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