Clinical trials: Impairment
Diabetes Mellitus, Type 2
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients…
- Trial name
- NCT01087502
- Testing
- Glimepiride, Linagliptin
- Where
- 52 sites in United States, Australia and 7 more
- Volunteers
- 241 people
- Sponsor
- Boehringer Ingelheim
Renal Impairment, Healthy Volunteers
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367.
- Trial name
- NCT05117294
- Testing
- Bocidelpar
- Where
- 4 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Anemia
Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
- Trial name
- NCT01318551
- Testing
- BAY85-3934
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bayer
Atrial Fibrillation
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
- Trial name
- NCT01721837
- Where
- 1,616 sites in Germany
- Volunteers
- 4,340 people
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.
- Trial name
- NCT05376839
- Testing
- Cedirogant
- Where
- 3 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AbbVie
Mild Cognitive Impairment, Adults
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition, inflammation, and dietary intake in adults…
- Trial name
- NCT05741047
- Testing
- a2Milk skim milk powder, Yili skim milk powder
- Where
- 2 sites in China
- Volunteers
- 96 people
- Sponsor
- a2 Milk Company Ltd.
Chronic Renal Insufficiency, Type 2 Diabetes Mellitus
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3…
- Trial name
- NCT01407276
- Testing
- Omarigliptin
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Mild Cognitive Impairment Due to Alzheimer's Disease
AD-4833/TOMM40_303 Extension Study of the Safety and Efficacy of Pioglitazone to Slow Cognitive Decline in Participants With Mild Cognitive Impairment Due to Alzheimer Disease
The purpose of this study is to evaluate the effect of pioglitazone at 24 months compared with placebo on cognitive decline in high-risk participants who have completed the AD-4833/TOMM40_301 study [NCT01931566] with an…
- Trial name
- NCT02284906
- Testing
- Pioglitazone
- Where
- 43 sites in United States, Australia and 2 more
- Volunteers
- 40 people
- Sponsor
- Takeda
Psoriatic Arthritis
Special Investigation in Patients With Psoriatic Arthritis (PsA) (Working Productivity and Activity Impairment [WPAI])
A special investigation (post marketing observational study [PMOS]/non-mandatory) of HUMIRA® in Japanese psoriatic arthritis patients who are engaged in paid work.
- Trial name
- NCT02414633
- Volunteers
- 148 people
- Sponsor
- AbbVie
Alzheimer Disease, Alzheimer's Disease (Incl Subtypes)
Prediction of Amyloid and Mild Cognitive Impairment in Early Stage Alzheimer's Disease From Remote Speech Phenotyping
The S22 study investigates, in a cross-sectional study, the ability of algorithms that analyse acoustic and linguistic patterns of spoken language to predict the presence of amyloid positivity in early stage Alzheimer's disease…
- Conditions
- Alzheimer Disease, Alzheimer's Disease (Incl Subtypes), Mild Cognitive Impairment
- Trial name
- EARS (NCT04928690)
- Volunteers
- 140 people
- Sponsor
- Novoic Limited
Renal Impairments, IgA Nephropathy (IgAN)
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous…
- Trial name
- NCT07445906
- Testing
- RG002C0106
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Diabetes Mellitus, Type 2
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.
- Trial name
- NCT01478399
- Testing
- PB1023 Injection
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Impaired Glucose Tolerance, Insulin Resistance
Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR
Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models.
- Trial name
- NCT01364155
- Testing
- LIM-0705
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Limerick BioPharma
Hepatic Impairment
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
- Trial name
- NCT03160014
- Testing
- SHR3824
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered…
- Trial name
- NCT02412449
- Testing
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Renal Impairment
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
Primary Objective: To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and…
- Trial name
- NCT01120314
- Testing
- OTAMIXABAN (XRP0673)
- Where
- 4 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine
This study will assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function.
- Trial name
- NCT00424671
- Testing
- Licarbazepine
- Where
- Czechia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis
Liver Failure
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with moderate hepatic impairment (Child Pugh score 7 9)…
- Trial name
- NCT02318836
- Testing
- Lofexidine Hydrochloride (HCl) tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
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