Clinical trials: Impairment
HIV Infections
Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia. Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle…
- Trial name
- NCT00002414
- Testing
- CPI-1189
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Centaur Pharmaceuticals
Alzheimer Disease
A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD
This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when…
- Trial name
- INTERCEPT-AD (NCT04931459)
- Testing
- ACU193
- Where
- 17 sites in United States
- Volunteers
- 65 people
- Sponsor
- Acumen Pharmaceuticals
Hepatic Impairment
A Study of JNJ-53718678 in Participants With Hepatic Impairment
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with…
- Trial name
- NCT04332523
- Testing
- JNJ-53718678
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- CAMPOLINA (NCT06812780)
- Testing
- AZD2389
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Impaired Hepatic Function, Healthy
Study of ALXN2050 in Participants With Hepatic Impairment
This study will investigate the impact of impaired hepatic function (IHF) on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with varying degrees of IHF.
- Trial name
- NCT05259085
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus, Renal Impairment
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate…
- Trial name
- NCT01555008
- Testing
- LX4211
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Lexicon Pharmaceuticals
Renal Impairment
Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of single subcutaneous dose of AZD6234 with end stage renal disease, severe, and possibly moderate and mild renal impairment in comparison to a matched…
- Trial name
- NCT06845813
- Testing
- AZD6234
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Healthy, Hepatic Insufficiency
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3437943 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
- NCT05916560
- Testing
- LY3437943
- Where
- 5 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Central Retinal Vein Occlusion
601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to CRVO
- Trial name
- NCT04667910
- Testing
- 601 1.25mg, Ranibizuman 0.5 mg
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Solid Tumours
A Phase I Topotecan Study in Subjects With Cancer and Impaired Renal Function
To determine the effect of renal impairment and prior platinum-based chemotherapy on the safety and blood levels of topotecan administered orally
- Trial name
- NCT00483860
- Testing
- Topotecan
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 59 people
- Sponsor
- GlaxoSmithKline
Renal Impairment
Pharmacokinetics of Besifovir in Adults With Normal and Impaired Renal Function
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of Besifovir and its metabolite, LB80331, in participants with normal and impaired renal function
- Trial name
- NCT04249908
- Testing
- Besifovir Dipivoxil Maleate
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Schizophrenia
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.
- Trial name
- NCT00848484
- Testing
- MK5757
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Pharmacokinetics
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal…
- Trial name
- NCT01084278
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Hearing Impaired (Partially)
Optimization of Perceived Sound Quality for Music Listening in Hearing Aid Users With Hearing Loss.
This study aims to optimize music listening quality for 66 hearing aid users (33 musicians and 33 non-musician music enthusiasts) by developing a dedicated "Music Program" based on individual frequency preference profiles.
- Trial name
- OPTIMMUSIC (NCT07677748)
- Testing
- Musical listening quality preference test
- Volunteers
- 66 people
- Sponsor
- Institut Pasteur
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
Healthy, Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod
This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).
- Trial name
- NCT04819464
- Testing
- Cenerimod
- Where
- 2 sites in Hungary, Portugal
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viatris Innovation GmbH
Chronic Kidney Disease
Renal Impairment Study for Oral EC5026
The goal of this Phase 1 clinical trial is to assess single dose pharmacokinetics of oral EC5026 in a population with chronic kidney disease. The main questions it aims to answer are: 1.
- Trial name
- NCT07694544
- Testing
- EC5026 oral tablet
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EicOsis Human Health Inc.
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