Clinical trials: Impairment
Kidney Disease
Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia
The purpose of this study is to characterize the safety and efficacy of repeat doses of compound 1278863A in subjects with anemia.
- Trial name
- NCT01047397
- Testing
- 1278863A
- Where
- 37 sites in Australia, India and 2 more
- Volunteers
- 107 people
- Sponsor
- GlaxoSmithKline
Impaired Glucose Tolerance, Insulin Resistance
Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR
Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models.
- Trial name
- NCT01364155
- Testing
- LIM-0705
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Limerick BioPharma
Healthy Participants
A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
The purpose of the study is to look at how the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function.
- Trial name
- NCT07231991
- Testing
- vepdegestrant
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dementia, Alzheimer Disease 1
Study of APH-1105 in Patients With Mild to Moderate Alzheimer's Disease
This is a Phase 2 study assessing the safety, tolerability and efficacy of intranasal delivery of APH-1105 for the treatment of mild to moderate Alzheimer's in adult.
- Conditions
- Dementia, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3
- Trial name
- NCT03806478
- Testing
- APH-1105
- Volunteers
- 60 people
- Sponsor
- Aphios
Atrial Fibrillation
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
- Trial name
- NCT01896297
- Testing
- Pradaxa, dabigatran etexilate
- Where
- 26 sites in United States
- Volunteers
- 63 people
- Sponsor
- Boehringer Ingelheim
Pharmacokinetics, Healthy Subjects
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Conditions
- Pharmacokinetics, Healthy Subjects, Mild and Moderate Hepatic Impairment
- Trial name
- NCT01579461
- Testing
- mirabegron
- Where
- Slovakia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Pathological Myopic Choroidal Neovascularization
601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
- Trial name
- NCT04922151
- Testing
- 601, Ranibizumab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Patients With Impaired Hepatic Function
Pharmacokinetics Study in Patients With Impaired Hepatic Function
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
- Trial name
- NCT02586194
- Testing
- ASP015K
- Where
- 6 sites in Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Diabetes Mellitus, Type 2
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular…
- Trial name
- Navigator (NCT00097786)
- Testing
- Valsartan 160 mg + nateglinide 60 mg
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 9,306 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease, Renal Impairment
A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide
The primary objective of the study is to estimate the PK parameters of ribupatide in participants with severe renal impairment or end-stage kidney disease (ESKD) after a single dose of ribupatide subcutaneous (SC) injection…
- Conditions
- End Stage Renal Disease, Renal Impairment, Obesity, Overweight
- Trial name
- NCT07793929
- Testing
- Ribupatide
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Kailera
Restless Legs Syndrome (RLS)
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
- Trial name
- NCT01981941
- Testing
- Gabapentin enacarbil
- Where
- 5 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
Mild Cognitive Impairment (MCI), Alzheimer Disease
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
- Trial name
- NCT05108922
- Testing
- Donanemab, Aducanumab
- Where
- 31 sites in United States
- Volunteers
- 148 people
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 2
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT02014259
- Testing
- semaglutide
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects
- Trial name
- NCT01529294
- Testing
- Iloperidone
- Where
- 4 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Ventricular Fibrillation, Ventricular Tachycardia
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
- Trial name
- IN-TIME (NCT00538356)
- Testing
- ICD or CRT-D with Home Monitoring feature deactivated, ICD or CRT-D with Home Monitoring feature activated
- Where
- 39 sites in Australia, Austria and 5 more
- Volunteers
- 720 people
- Sponsor
- Biotronik SE & Co. KG
Alzheimer Disease
A Study of LY3002813 in Participants With Alzheimer's Disease
The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813.
- Trial name
- NCT01837641
- Testing
- LY3002813-IV, LY3002813-SC
- Where
- 6 sites in United States, Japan
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Human Immunodeficiency Virus (HIV) Infection
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with…
- Trial name
- NCT04515641
- Testing
- Islatravir
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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