Clinical trials: Impairment
Macular Edema, Retinal Vein Occlusion
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
- Trial name
- BEACON (NCT04592419)
- Testing
- KSI-301, Aflibercept
- Where
- 141 sites in United States, Czechia and 10 more
- Volunteers
- 568 people
- Sponsor
- Kodiak Sciences Inc
Psoriasis
A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life
The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque…
- Trial name
- EMBRACE (NCT03774875)
- Testing
- Apremilast
- Where
- 72 sites in France, Germany and 4 more
- Volunteers
- 277 people
- Sponsor
- Amgen
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
- Trial name
- NCT03587363
- Testing
- Erdafitinib
- Where
- 2 sites in Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Insufficiency
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
- Trial name
- NCT00781430
- Testing
- Neratinib (HKI-272)
- Where
- Russia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Patients With Mild or Moderate Hepatic Impairment
A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
- Trial name
- NCT07231029
- Testing
- TS-172
- Where
- Japan
- Volunteers
- 24 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Cadmium Exceeds the Standard
Study on Neuropsychiatric Behavior in Cadmium-exposed People
This study hypothesized that excessive cadmium is related to clinical pain, depression, and cognitive impairment, and that related indicators will improve after cadmium is eliminated.
- Trial name
- NCT06572566
- Testing
- Non-invasive examination and assessment.
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
Diabetes
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
- Trial name
- NCT06547502
- Testing
- GZR4
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Healthy Volunteers, Patients
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
- Conditions
- Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment
- Trial name
- NCT01240967
- Testing
- TC-5214
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose.
- Trial name
- NCT05599932
- Testing
- Siremadlin
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
- Trial name
- NCT07012005
- Testing
- BPN14770
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Shionogi
Non-valvular Atrial Fibrillation (NVAF)
Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions.
- Trial name
- XARENAL (NCT03746301)
- Testing
- Rivaroxaban(Xarelto,BAY 59-7939)
- Where
- South Korea
- Volunteers
- 924 people
- Sponsor
- Bayer
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Gout
Mild, Moderate and Severe Renal Impairment Study
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
- Trial name
- NCT02219516
- Testing
- RDEA3170
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Ardea Biosciences, Inc.
Vaccine Response Impaired
Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)
This study evaluated whether it is possible in healthy elderly participants to generate baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute serum antibody titer) using each of the protocol…
- Trial name
- NCT01119703
- Testing
- Tetanus & Diphtheria booster vaccine (Td), TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Insufficiency
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
- Trial name
- NCT02320045
- Testing
- ITCA 650 (Exenatide in osmotic mini pump)
- Where
- 4 sites in United States, Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Intarcia Therapeutics
Secondary Hypogonadism
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- Trial name
- NCT01923870
- Testing
- Androxal 25 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Alzheimer Disease
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI…
- Trial name
- NCT06247345
- Testing
- ADEL-Y01 - healty participants, ADEL-Y01 - MCI/AD
- Where
- 6 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alzheimer's Disease Expert Lab (ADEL), Inc.
Overweight, Obesity
Effects of Obex in Overweight and Obese Patients
Obesity is an important and growing public health worldwide Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer An extensive body of evidence from efficacy trials has…
- Trial name
- NCT02145442
- Testing
- Obex
- Where
- Cuba
- Volunteers
- 40 people
- Sponsor
- Catalysis SL
Alzheimer's Disease
A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored.
- Trial name
- NCT02754830
- Testing
- LY3303560 - IV, Saline Solution - IV, LY3303560 - SC
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment
Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients
This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function
- Trial name
- NCT03506854
- Testing
- ISIS 681257
- Where
- 3 sites in United States, Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Akcea Therapeutics