Clinical trials: Impairment
Inflammatory Disease
Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls.
- Trial name
- NCT02959138
- Testing
- Lanraplenib.
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Alzheimer's Disease
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Trial name
- MINDSET 1 (NCT06976216)
- Testing
- KarXT, KarX-EC
- Where
- 119 sites in United States, Argentina and 17 more
- Volunteers
- 586 people
- Sponsor
- Bristol-Myers Squibb
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
- Trial name
- NCT07152288
- Testing
- HSK39297 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Renal Impairment
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
- Trial name
- NCT07559396
- Testing
- INCB123667
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Diabetic Macular Edema (DME)
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
- Trial name
- ALTO (NCT07734844)
- Testing
- Tabirafusp tedromer, Aflibercept (2.0 mg)
- Where
- 9 sites in United States
- Volunteers
- 910 people
- Sponsor
- Kodiak Sciences Inc
Hypertrophic Cardiomyopathy
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Trial name
- NCT06775834
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Multiple Sclerosis
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.
REPAIR-MS is a single-center open label, 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 diagnosed…
- Trial name
- REPAIR-MS (NCT03993171)
- Testing
- gold nanocrystals
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Clene Nanomedicine
Gout, Moderate Renal Impairment
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants…
- Trial name
- NCT02128490
- Testing
- Febuxostat IR, Febuxostat XR, Colchicine
- Where
- 89 sites in United States
- Volunteers
- 189 people
- Sponsor
- Takeda
Hepatic Impairment
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
- Trial name
- NCT04859426
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Age-related Functional Decline, Mild Cognitive Impairment
Health Benefits of Nutraceutical Supplementation in Older Adults.
This study examines a multi-ingredient nutraceutical designed to support several areas of health in older adults, including muscle strength, cognitive function, immune response, and inflammation.
- Trial name
- NCT07534878
- Testing
- Powder containing whey isolate and herbal extracts (30g sachet)
- Where
- India
- Volunteers
- 23 people
- Sponsor
- GPLIFE HEALTHCARE PRIVATE LIMITED
Diabetes Mellitus
Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06961643
- Testing
- HRS-7535 Tables
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN).
- Conditions
- Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater, Balance, Balance Impairment, Gait Disorders, Fatigue
- Trial name
- NCT07554443
- Testing
- External, lower limb sensory prosthesis
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- RxFunction Inc.
Healthy
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib
- Trial name
- NCT00418626
- Testing
- Nilotinib
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems
This study will be conducted to look at the effect of decreased kidney function when getting one dose of insulin 287 and to guide dosing recommendations in people who have altered kidney function.
- Trial name
- NCT03723785
- Testing
- Insulin icodec
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Early Alzheimer's Disease
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
- Trial name
- NCT02859207
- Testing
- E2609
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Diabetes, Diabetes Mellitus, Type 2
Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Hepatic Impaired
- Trial name
- NCT02210871
- Testing
- semaglutide
- Where
- 4 sites in Poland, Slovakia
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
Healthy Volunteer
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with…
- Trial name
- NCT01714154
- Testing
- danoprevir, ritonavir, setrobuvir
- Where
- 3 sites in Hungary, Poland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
- Trial name
- NCT02802345
- Testing
- Nintedanib, Sildenafil
- Where
- 85 sites in United States, Australia and 11 more
- Volunteers
- 274 people
- Sponsor
- Boehringer Ingelheim
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