Clinical trials: Impairment
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Hepatic Impairment, Healthy Subjects
The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics
This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).
- Trial name
- NCT04252495
- Testing
- Aprocitentan
- Where
- 2 sites in Germany, Poland
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Smoking
Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms
A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers.
- Trial name
- NCT00657020
- Testing
- Nicotine
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic impairment PK study
- Trial name
- NCT03309202
- Testing
- PF-05221304
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Impaired Glucose Tolerance
Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability
The purpose of this study is to determine the short-term effect of a nutritional program consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic variability in men and women with risk factors…
- Trial name
- NCT05493553
- Testing
- Dietary supplement regimen, Dietary supplement and intermittent fasting regimen
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Unicity International, Inc.
Alzheimer Disease, Early Onset, Cognitive Impairment
Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease
Two devices will be tested in this research: 1. Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation). 2.
- Conditions
- Alzheimer Disease, Early Onset, Cognitive Impairment, Cognitive Decline
- Trial name
- NCT05604183
- Testing
- non-invasive hyperspectral retinoscopy, blood sample, Test of cognitive ability on tablet computer with CoGNIT software
- Where
- 2 sites in Sweden
- Volunteers
- 80 people
- Sponsor
- Mantis Photonics AB
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
Parkinson's Disease, PD
iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS
The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for…
- Conditions
- Parkinson's Disease, PD, Mild Cognitive Impairment, MCI
- Trial name
- iPACES-PD (NCT05810454)
- Testing
- iPACES (interactive Physical and Cognitive Exercise System), PACE (Physical and Cognitive Exercise)
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- iPACES LLC
Renal Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects…
- Trial name
- NCT04859439
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with…
- Trial name
- NCT03605277
- Testing
- Asciminib
- Where
- 2 sites in Bulgaria, Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetic Kidney Disease (DKD)
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on participants who have diabetic kidney disease.
- Trial name
- ANCHOR-POC (NCT07271186)
- Testing
- ALN-ANG3, Evinacumab
- Where
- 59 sites in United States
- Volunteers
- 195 people
- Sponsor
- Regeneron Pharmaceuticals
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
Renal Impairment
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
- Trial name
- NCT01452828
- Testing
- TR-701 FA single infusion, TR-701 FA
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Parkinson Disease
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive…
- Trial name
- NCT03713957
- Testing
- GRF6021
- Where
- 29 sites in United States, Australia and 1 more
- Volunteers
- 79 people
- Sponsor
- Alkahest, Inc.
Neurologic Impairment by Opioids
Non-intrusive Detection of Temporary Neurologic Impairment by Opioids
The investigators aim to prove the feasibility of a non-invasive means to identify temporary neurological impairment resulting from the use of a commonly prescribed opioid by identifying an oculomotor biosignature associated with…
- Trial name
- NCT05489601
- Testing
- Oxycodone
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Zxerex Corporation
Alzheimers Disease
Clinical Utility of Early vs. Late Blood Biomarker Testing for Alzheimer's Disease
The goal of this study is to evaluate whether use of the PrecivityAD2 blood biomarker assay with early result disclosure along with discretionary Precivity-ApoE proteotype testing will shorten the time to Alzheimer's Disease or…
- Trial name
- ADELAIDE (NCT06856681)
- Testing
- PrecivityAD2 - Early Testing, PrecivityAD2 - Delayed Testing
- Sponsor
- C2N Diagnostics