Clinical trials: Impairment
Non-alcoholic Steatohepatitis (NASH)
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver.
- Trial name
- NCT05727644
- Testing
- NNC0194-0499
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Mild Cognitive Impairment, Alzheimer's Disease
Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease Related Disorders
- Trial name
- NCT01745198
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Pamlab, Inc.
Mucopolysaccharidosis (MPS), Hunter Syndrome
Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S).
- Trial name
- NCT01822184
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 100 people
- Sponsor
- Shire
Glucose Lowering
To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.
- Trial name
- NCT01069926
- Testing
- AZD1656
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
Anemia, Kidney Disease
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
- Trial name
- NCT01235936
- Testing
- AKB-6548
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Akebia Therapeutics
Hepatic Impairment
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.
- Trial name
- NCT01433458
- Testing
- RLX030A
- Where
- 2 sites in Germany, Russia
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Insufficiency
Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment
The primary objectives were: To determine the effects of steady state TPV co-administered with low dose RTV on steady state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A) To determine the effects…
- Trial name
- NCT02259855
- Testing
- Tipranavir, Ritonavir, Pegylated interferon
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Pharmacokinetics of Besifovir in Adults With Normal and Impaired Renal Function
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of Besifovir and its metabolite, LB80331, in participants with normal and impaired renal function
- Trial name
- NCT04249908
- Testing
- Besifovir Dipivoxil Maleate
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Hepatic Impairment
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Mild Cognitive Impairment
Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System
This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through EEG recordings while listening to an…
- Trial name
- NCT04683835
- Testing
- Neurosteer Aurora system
- Where
- Israel
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Neurosteer Ltd.
Impaired Fasting Glucose
The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population
The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG).
- Trial name
- NCT02119325
- Testing
- 25% fibre, 0% fibre
- Where
- India
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Memory Impairment, Alzheimer's Disease
Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults
The purpose of this study is to determine whether scopolamine-induced cognitive impairment is attenuated by the administration of roflumilast in combination with donepezil.
- Trial name
- NCT02051335
- Testing
- Roflumilast, Donepezil, Scopolamine
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy, Renal Insufficiency
Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074.
- Trial name
- NCT02653014
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Hepatic Impairment
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing…
- Trial name
- NCT01516047
- Testing
- Cohort 1, Cohort 2
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Hepatitis C
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Trial name
- NCT01817985
- Testing
- GS-5816
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN).
- Conditions
- Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater, Balance, Balance Impairment, Gait Disorders, Fatigue
- Trial name
- NCT07554443
- Testing
- External, lower limb sensory prosthesis
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- RxFunction Inc.
Urinary Retention, Chronic
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.
- Trial name
- NCT05330598
- Testing
- Connected Catheter
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Spinal Singularity
Hepatic Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Liver Damage
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems.
- Trial name
- NCT05976321
- Testing
- TAK-279
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatic Function Abnormal, Healthy Volunteers
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
- Trial name
- NCT06444204
- Testing
- Rilzabrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
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