Clinical trials: Impairment
Pharmacokinetic
A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol
The objective of this study was to evaluate the pharmacokinetics (PK), safety and tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal impairment and participants with normal renal function…
- Trial name
- NCT03882762
- Testing
- Cebranopadol 200 μg tablet
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Tris Pharma, Inc.
Hepatic Impairment, Healthy Volunteers
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
- Trial name
- NCT04604496
- Testing
- PF-06882961 20MG
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Cystic Fibrosis, Motor Neuron Disease
MN4000 for Treatment of CF and MND Patients in the Home Setting
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
- Conditions
- Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment
- Trial name
- NCT03797677
- Testing
- MN 4000
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Chronic Hepatitis C Virus (HCV) Infection
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.
- Trial name
- EXPEDITION-4 (NCT02651194)
- Testing
- ABT-493/ABT-530
- Volunteers
- 104 people
- Sponsor
- AbbVie
Dementia, Alzheimer Disease
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.
- Trial name
- NCT00236431
- Testing
- Galantamine hydrobromide
- Volunteers
- 1,063 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Alzheimer Disease, Cognitive Impairment
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium…
- Trial name
- NCT01453569
- Testing
- Sodium oligo-mannurarate 600mg, Sodium oligo-mannurarate 900mg
- Where
- 24 sites in China
- Volunteers
- 255 people
- Sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT02354937
- Testing
- GSK1265744 30 mg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- ViiV Healthcare
Relapsed/Refractory Solid Tumors/Hematological Malignancies
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment.
- Trial name
- NCT02679131
- Testing
- Belinostat
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Acrotech Biopharma Inc.
Healthy, Hepatic Impairment
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with…
- Trial name
- NCT07486102
- Testing
- BI 3000202
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment
Surufatinib Hepatic Impairment Study
An open-label, multicenter, single-dose, single-period, sequential study to determine the effect of hepatic impairment on the PK of surufatinib.
- Trial name
- NCT04755075
- Testing
- Surufatinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Diabetes Mellitus Type 2
A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of…
- Trial name
- NCT01043029
- Testing
- aleglitazar, pioglitazone
- Where
- 80 sites in Australia, Brazil and 11 more
- Volunteers
- 302 people
- Sponsor
- Hoffmann-La Roche
Diabetic Kidney Disease
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
- Trial name
- NCT06666283
- Testing
- AP303 150μg
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Alebund Pharmaceuticals
Pulmonary Arterial Hypertension
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy…
- Trial name
- TripleTRE (NCT06317805)
- Testing
- Generic treprostinil sodium + Standard of Care (Double Oral), Standard of Care - Double Oral
- Where
- 28 sites in Argentina, Austria and 10 more
- Volunteers
- 110 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Alzheimer's Disease (AD)
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
- Trial name
- NCT06114745
- Testing
- SHR-1707 injection
- Where
- 3 sites in Australia
- Volunteers
- 2 people
- Sponsor
- Atridia Pty Ltd.
Mild Cognitive Impairment, Alzheimer Disease
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive impairment due to Alzheimer's Disease
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Alzheimer Dementia, Dementia, Vascular
- Trial name
- NCT03538522
- Testing
- N-831(Traneurocin) 10 mg QD, NA-831 (Traneurocin) 20 mg QD, NA-831 (Traneurocin) 40 mg QD
- Where
- 2 sites in New Zealand
- Volunteers
- 126 people
- Sponsor
- Biomed Industries, Inc.
Bone Metabolism
Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.
- Trial name
- NCT00708175
- Testing
- Pioglitazone
- Where
- 34 sites in United States
- Volunteers
- 156 people
- Sponsor
- Takeda
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
Healthy Participants, Gastrointestinal Neoplasms
A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib
This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.
- Trial name
- NCT07859735
- Testing
- Velzatinib
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Amyotrophic Lateral Sclerosis
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)
REPAIR-ALS is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been…
- Trial name
- REPAIR-ALS (NCT03843710)
- Testing
- Gold Nanocrystals
- Where
- United States
- Sponsor
- Clene Nanomedicine
Hepatic Insufficiency
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT00968591
- Testing
- Everolimus
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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