Clinical trials: Severe Functional Impairment
Renal Impairment
Safinamide Renal Impairment Trial
The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal…
- Trial name
- NCT01374113
- Testing
- 50mg safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Hepatic Impairment
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy…
- Trial name
- NCT04190654
- Testing
- KW-6356
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin, Inc.
Renal Impairment, Normal Renal Function
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild \& moderate) compared to male and female subjects with normal renal function.
- Trial name
- NCT04656795
- Testing
- MT-7117
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma America, Inc.
Multiple Sclerosis
Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in Multiple Sclerosis
The aim of the study is to evaluate the safety, feasibility and initial efficacy of an interval-based walking training at low speed performed with blood flow restriction (BFR) on gait speed and functional impairments in patients…
- Trial name
- NCT03544177
- Testing
- BFR-Walking, Conventional therapy
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- University Hospital of Ferrara
Covid19
Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19).
- Trial name
- REHABCOV (NCT04681755)
- Where
- France
- Volunteers
- 55 people
- Sponsor
- University Hospital, Strasbourg, France
Healthy
BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function
Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler)
- Trial name
- NCT02172118
- Testing
- BI 1774 CL
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes, Healthy
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects…
- Trial name
- NCT00976326
- Testing
- insulin degludec
- Where
- Slovakia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Renal Impairment
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects…
- Trial name
- NCT01763190
- Testing
- SAR302503
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Insufficiency, Neoplasms
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
- Trial name
- NCT05209295
- Testing
- Onureg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 2 people
- Sponsor
- Bristol-Myers Squibb
Renal Impairment
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.
- Trial name
- NCT01082640
- Testing
- Febuxostat
- Where
- 58 sites in United States
- Volunteers
- 96 people
- Sponsor
- Takeda
Hepatic Impairment, Healthy
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy…
- Trial name
- NCT06908954
- Testing
- Palovarotene
- Where
- 4 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Ipsen
Transdiagnostic, Depression - Major Depressive Disorder
Open-Label Psilocybin Study in Transdiagnostic Population
The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms.
- Conditions
- Transdiagnostic, Depression - Major Depressive Disorder, Anxiety, PTSD Symptoms
- Trial name
- NCT06442423
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yale University
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Alzheimer s Disease
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression.
- Trial name
- DCLVA-AD (NCT07669272)
- Testing
- Deep Cervical Lymphovenous Anastomosis, Routine Treatment
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Southwest Hospital, China
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
Renal Impairment
Pharmacokinetics in Subjects With Renal Impairment
This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different grades of renal impairment as…
- Trial name
- NCT01504165
- Testing
- cilengitide 2000mg, cilengitide 1000mg, cilengitide > 1000mg and up to 2000mg
- Where
- 2 sites in Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Renal Impairment
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
VI-0521, a fixed dose combination of immediate-release (IR) phentermine and controlled-release (CR) topiramate, is in Phase III clinical development as a potential therapy for obesity.
- Trial name
- NCT00768404
- Testing
- Topirmate and Phentermine
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Solid Tumours
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function
- Trial name
- NCT02923947
- Testing
- Osimertinib; AZD9291
- Where
- 11 sites in France, South Korea and 1 more
- Volunteers
- 16 people
- Sponsor
- AstraZeneca