Clinical trials: Impairment
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Type 2 Diabetes Mellitus
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
- Trial name
- NCT01097681
- Testing
- ASP1941
- Where
- 2 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Inc
Liver Disease
Hepatic Impairment Study
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose.
- Trial name
- NCT00829231
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 3 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bayer
Neoplasm Malignant
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Primary Objectives: To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment To determine the pharmacokinetics (PKs) of…
- Trial name
- NCT01140607
- Testing
- Cabazitaxel (XRP6258)
- Where
- 14 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sanofi
Healthy, Renal Impairment
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
- Trial name
- NCT06352411
- Testing
- BI 456906
- Where
- 2 sites in Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal…
- Trial name
- NCT07741604
- Testing
- RO7795081
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Advanced Cancer
Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients.
- Trial name
- NCT01576406
- Testing
- crizotinib
- Where
- 20 sites in United States
- Volunteers
- 88 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 2
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees…
- Trial name
- NCT01508806
- Testing
- liraglutide
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
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
Advanced Solid Tumors, Hematologic Malignancies
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing…
- Trial name
- SPI-FOL-102 (NCT07036133)
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acrotech Biopharma Inc.
Renal Insufficiency, Healthy
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.
The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared…
- Trial name
- NCT05936138
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Liver Disease
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
- Trial name
- NCT01370148
- Testing
- conivaptan hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Malnutrition
Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.
- Trial name
- PRESAGE-T2 (NCT02117609)
- Testing
- New DELICAL formula, Standard DELICAL formula
- Where
- France
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Lactalis
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
Alzheimer Disease, Alzheimer's Disease (Incl Subtypes)
Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on…
- Conditions
- Alzheimer Disease, Alzheimer's Disease (Incl Subtypes), Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
- Trial name
- PAST-US (NCT04937959)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novoic Limited
Renal Impairment
Effect of Renal Impairment on Enpatoran Pharmacokinetics
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
- Trial name
- NCT06589713
- Testing
- Enpatoran
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Hepatic Impairment
A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects
The investigators are doing this study to find out if tucatinib is safe for patients with liver problems. This study will look at participants with mild, moderate, and severe liver problems.
- Trial name
- NCT03722823
- Testing
- Tucatinib
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Seagen Inc.
Anaemia
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent.
- Trial name
- NCT01406340
- Testing
- 5 mg GSK1278863
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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