Clinical trials: Impairment
Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe…
- Trial name
- NCT05660395
- Testing
- Loncastuximab Tesirine
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 5 people
- Sponsor
- ADC Therapeutics S.A.
End Stage Renal Disease, Renal Impairment
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD)…
- Trial name
- NCT04994522
- Testing
- Belzutifan
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment, Renal Impairment
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
- Trial name
- NCT05112419
- Testing
- Zibotentan
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Multi-resistant Gram-negative Bacteria Cause Infection
To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the…
- Trial name
- NCT06522945
- Testing
- TQD3524
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Hepatic Impairment
BG9928 in Subjects With Hepatic Impairment
The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic…
- Trial name
- NCT00858156
- Testing
- BG9928
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Biogen
Multiple Myeloma
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function
Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb).
- Trial name
- DREAMM12 (NCT04398745)
- Testing
- Belantamab mafodotin
- Where
- 4 sites in Greece, South Korea
- Volunteers
- 36 people
- Sponsor
- GlaxoSmithKline
Parkinson Disease, Freezing of Gait
Use of CereGate Therapy for Freezing of Gait in PD
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
- Conditions
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Trial name
- NCT05292794
- Testing
- CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- CereGate Inc.
Moderate Hepatic Impairment
A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched…
- Trial name
- NCT04995484
- Testing
- Belzutifan
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Disease
Safety and Efficacy Study of A0001 in Patients With the A3243G Mitochondrial DNA Point Mutation
This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one patients who qualify for the study will be randomly assigned to either active drug or placebo.
- Trial name
- NCT01074359
- Testing
- A0001 (alpha-tocopherolquinone)
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Penwest Pharmaceuticals Co.
Sepsis
A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver.
- Trial name
- NCT00158769
- Testing
- Intravenous GR270773 - Phospholipid emulsion
- Where
- Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Impaired Hepatic Function
Evaluating Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic…
- Trial name
- NCT00398424
- Testing
- S-1/Cisplatin
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Renal Impairment
EVP-6124 Renal Impairment Study
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe renal impairment compared with subjects with normal renal function.
- Trial name
- NCT01984723
- Testing
- Experimental: EVP-6124
- Where
- 2 sites in Czechia, Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- FORUM Pharmaceuticals Inc
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Hearing Impairment
A Study Examining Acceptability of Auditory Implant Fitting Software Technologies
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss.
- Trial name
- SUNRISE-MU (NCT07763873)
- Testing
- Investigational Software
- Where
- 2 sites in United States, Australia
- Volunteers
- 200 people
- Sponsor
- Cochlear
Heart Failure
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response…
- Trial name
- SymplicityHF (NCT01392196)
- Testing
- Renal Denervation
- Where
- Australia
- Volunteers
- 39 people
- Sponsor
- Medtronic Vascular
Infectious Diseases
A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan. Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
- Trial name
- NCT06864585
- Testing
- Avibactam sodium/Ceftazidime hydrate
- Where
- Japan
- Volunteers
- 59 people
- Sponsor
- Pfizer
Mild Cognitive Impairment, Adults
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition, inflammation, and dietary intake in adults…
- Trial name
- NCT05741047
- Testing
- a2Milk skim milk powder, Yili skim milk powder
- Where
- 2 sites in China
- Volunteers
- 96 people
- Sponsor
- a2 Milk Company Ltd.
Renal Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
- Trial name
- NCT03289208
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Insufficiency, Renal Impairment
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with…
- Trial name
- NCT02011490
- Testing
- sugammadex
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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