Clinical trials: Severe Functional Impairment
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
Renal Insufficiency
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.
- Trial name
- NCT05718843
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Depression, Major Depressive Disorder
Memory Functioning and Antidepressant Treatment
Major Depressive Disorder (MDD) is a serious illness associated with considerable morbidity, risk of suicide and adverse social consequences (Montgomery et al., 1994a).
- Trial name
- NCT00296933
- Testing
- Escitalopram, Bupropion XL
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- University Health Network, Toronto
Renal Impairment, Healthy Volunteer
A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function
This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment.
- Trial name
- NCT03192111
- Testing
- Entinostat
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Syndax Pharmaceuticals
Severe Hepatic Impairment, Normal Hepatic Function
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
The influence of severely diminished liver function on the metabolism, safety, and tolerability of a single oral dose of enzalutamide in a group of 8 men.
- Trial name
- NCT02138162
- Testing
- enzalutamide
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Renal Insufficiency
Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e.
- Trial name
- NCT01766154
- Testing
- Tirofiban
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medicure
Renal Impaired, Gilteritinib
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal…
- Conditions
- Renal Impaired, Gilteritinib, Normal Renal Function, Pharmacokinetics of ASP2215
- Trial name
- NCT04699877
- Testing
- Gilteritinib
- Where
- 4 sites in United States, Bulgaria
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Renal Impairment
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
- Trial name
- NCT00999336
- Testing
- Betrixaban
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Mild Cognitive Impairment in Middle-aged Adults
Deafness and Cognition in Middle-aged Adults
A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years.
- Trial name
- SURDICOG (NCT05149742)
- Testing
- Cognitive and audiometry evaluation
- Where
- France
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Liver Transplant, Erector Spina Plan Block
Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients
The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant.
- Trial name
- NCT06857331
- Testing
- Erector Spinae Plane Block using 0.2% ropivacaine
- Where
- Ukraine
- Volunteers
- 50 people
- Sponsor
- Bogomolets National Medical University
Consciousness Disorder, Cognitive Impairment
Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness.
- Trial name
- NCT05802524
- Testing
- Neurowave Group
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
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.
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Renal Impairment
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Trial name
- NCT06318676
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
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