Clinical trials: Impairment
Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background…
- Trial name
- Eluminate-4 (NCT07662135)
- Testing
- Elecoglipron
- Where
- 186 sites in United States, Bulgaria and 14 more
- Volunteers
- 900 people
- Sponsor
- AstraZeneca
Fall, Mild Cognitive Impairment (MCI)
Digital STEADI Efficacy
The aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older…
- Conditions
- Fall, Mild Cognitive Impairment (MCI), Aging
- Trial name
- NCT07852650
- Testing
- Digital STEADI-1, STEADI Standard of Care, Digital STEADI-2
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Friendi.fi Corporation
Renal Impairment
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
Primary Objective: To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects Secondary Objective: To assess the…
- Trial name
- NCT01239459
- Testing
- Teriflunomide HMR1726, Cholestyramine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- Sanofi
Hepatic Insufficiency
Study of Telaprevir in Subjects With Hepatic Impairment
The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.
- Trial name
- NCT00509210
- Testing
- telaprevir (VX-950)
- Where
- United States
- Sponsor
- Vertex Pharmaceuticals Incorporated
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.
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
Retinal Vein Occlusion
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the…
- Trial name
- NCT01580020
- Testing
- RFB002, Dexamethasone
- Where
- 37 sites in Germany
- Volunteers
- 175 people
- Sponsor
- Novartis Pharmaceuticals
Healthy, Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-42847922 in adult participants with hepatic impairment when compared to healthy participants with normal hepatic function.
- Trial name
- NCT04960124
- Testing
- JNJ-42847922
- Where
- 2 sites in Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Renal Impairment
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.
- Trial name
- NCT01028768
- Testing
- Teduglutide
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Nycomed
Hepatic Impairment
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
- Trial name
- NCT04276662
- Testing
- DS-3201b
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Impairment
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
This is an open-label, single-dose study designed to assess the pharmacokinetics and safety of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to those in subjects with normal hepatic function.
- Trial name
- NCT02296905
- Testing
- ABT-493, ABT-530
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AbbVie
Psoriasis
An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO)
The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation…
- Trial name
- IMMagine (NCT05959070)
- Where
- 16 sites in Belgium, Canada and 1 more
- Volunteers
- 154 people
- Sponsor
- AbbVie
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
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.
COVID-19 Pneumonia, Impaired Respiratory Function
Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia
This clinical study was designed to assess the efficacy and safety of DFV890 for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infected patients with coronavirus disease 2019 (COVID-19) pneumonia…
- Trial name
- NCT04382053
- Testing
- DFV890, Standard of Care (SoC)
- Where
- 29 sites in Argentina, Brazil and 10 more
- Volunteers
- 143 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Non-small Cell Lung Cancer
Pharmacokinetic Study of HS-10241 Tablets in Subjects with Hepatic Impairment and Normal Hepatic Function
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages.
- Trial name
- NCT06823245
- Testing
- HS-10241
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Stroke, Cerebrovascular Accident
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after…
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Trial name
- AMES (NCT01378637)
- Testing
- AMES- Leg treatment
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- AMES Technology
Renal Impairment, Healthy
Study of ALXN2050 in Participants With Renal Impairment
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
- Trial name
- NCT04623710
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Driving Impaired
Driving Simulation to Assess Non-Sedative Effects of Tolperisone
This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and cognitive functioning in healthy adult volunteers.
- Trial name
- NCT03353922
- Testing
- Cyclobenzaprine 10 Mg Oral Tablet
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Neurana Pharmaceuticals, Inc.
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