Clinical trials: Functional Impairment
Hepatitis C, Chronic
Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic…
- Trial name
- NCT01919125
- Testing
- IDX719
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cardiovascular Disease
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment…
- Trial name
- NCT01825889
- Testing
- Evacetrapib
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Liver Dysfunction, Liver Insufficiency
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
- Conditions
- Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure
- Trial name
- NCT03515980
- Testing
- BMS-986231
- Where
- 4 sites in Hungary, Poland
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Renal Impairment
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
- Trial name
- CINOPSIS CT (NCT00793182)
- Testing
- Ioversol 320 mgI/mL, Iodixanol 320 mgI/mL
- Where
- 13 sites in United States
- Volunteers
- 6 people
- Sponsor
- Guerbet
Hepatic Impairment
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with…
- Trial name
- NCT01027169
- Testing
- safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
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
Type 2 Diabetes Mellitus
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.
- Trial name
- NCT01316094
- Testing
- ASP1941
- Where
- 8 sites in Japan
- Volunteers
- 165 people
- Sponsor
- Astellas Pharma Inc
Hepatic Impairment
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
- Trial name
- NCT00819468
- Testing
- Teduglutide
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shire
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with…
- Trial name
- NCT04056468
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Pre-Eclampsia, Hypertension
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
- Conditions
- Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia
- Trial name
- NCT03767803
- Testing
- Non-interventional study
- Where
- 24 sites in United States
- Volunteers
- 344 people
- Sponsor
- Progenity, Inc.
Hypertension
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function.
- Trial name
- NCT05961397
- Testing
- baxdrostat
- Where
- 5 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Acute Kidney Injury
Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different…
- Trial name
- NCT02772276
- Testing
- MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg, MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart
- Where
- 3 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Renal Insufficiency, Kidney Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624710
- Testing
- INCB054707
- Where
- 4 sites in United States, Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Blood Pressure, HDL Low
Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
This open-label field trial evaluates the effects of treatment with a multi-pathway dietary supplement (Stem Cell 100+) that has been commercially available for several years.
- Conditions
- Blood Pressure, HDL Low, Stress, Lung Function Decreased
- Trial name
- NCT03052491
- Testing
- Stem Cell 100+
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Centagen, 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 Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal…
- Trial name
- NCT03189498
- Testing
- JNJ-64041575
- Where
- 2 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Multiple Myeloma, Renal Impairment
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and…
- Trial name
- POM Renal (NCT01575925)
- Testing
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Celgene
Hepatic Impairment
GT-032 Belapectin Hepatic Impairment
This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched…
- Trial name
- NCT04332432
- Testing
- belapectin
- Where
- 4 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Galectin Therapeutics Inc.
Renal Insufficiency
Afatinib in Subjects With Kidney Dysfunction
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal…
- Trial name
- NCT02096718
- Testing
- Afatinib healthy, Afatinib severe renally impaired, Afatinib moderate renally impaired
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim