Clinical trials: Functional Impairment
Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
This was a multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 in participants with chronic hepatic impairment relative to matched participants with normal hepatic…
- Trial name
- NCT06736223
- Testing
- ITF2357
- Where
- 3 sites in Bulgaria, France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Italfarmaco
Mild Cognitive Impairment (MCI), Mild Alzheimer Disease
Self-Administered Interactive Exercise Program (Tele-Exergame)
This longitudinal Phase I feasibility trial combines care-as-usual with a 6-week, single-arm exercise intervention using Tele-Exergame, an interactive, self-administered home-based exercise program aimed at improving…
- Conditions
- Mild Cognitive Impairment (MCI), Mild Alzheimer Disease, Memory Deficits
- Trial name
- NCT07072962
- Testing
- home-based self-administered interactive exercise
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Baylor College of Medicine
Renal Insufficiency, Healthy
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
- Trial name
- NCT03302091
- Testing
- BI 1467335
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773
- Trial name
- NCT01907113
- Testing
- BI 10773
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Impaired Fasting Glucose, Prediabetes
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous…
- Trial name
- NCT00990184
- Testing
- Colesevelam
- Volunteers
- 21 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Hepatic Insufficiency
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
- Trial name
- NCT00692341
- Testing
- AG-013736
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Impaired Glucose Tolerance
Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance
Resveratrol is a substance found in many plants, including grapes and red wine, which is widely used as a nutritional supplement.
- Trial name
- RSV (NCT01375959)
- Testing
- resveratrol
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Albert Einstein College of Medicine
PTSD, Depression
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective…
- Conditions
- PTSD, Depression, Chronic Pain, Alcohol Use Disorder
- Trial name
- SERVE:IMPACT (NCT03615222)
- Where
- 2 sites in United States
- Volunteers
- 377 people
- Sponsor
- VA Office of Research and Development
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
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alcohol Dependence, Bipolar Disorder
Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their…
- Conditions
- Alcohol Dependence, Bipolar Disorder, Depression, Mania
- Trial name
- NCT01015586
- Testing
- Lamotrigine
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Medical University of South Carolina
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy, Hepatic Insufficiency
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants.
- Trial name
- NCT06190691
- Testing
- Pirtobrutinib
- Where
- 8 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Impaired Renal Function
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
- Trial name
- NCT03776539
- Testing
- ELX-02
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eloxx Pharmaceuticals, Inc.
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
Healthy Subjects, Renal Impairments
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of…
- Trial name
- NCT01491113
- Testing
- Levetiracetam 250 mg, Levetiracetam 500 mg
- Where
- 2 sites in Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Impaired Glucose Tolerance, Oxidative Stress
Effect of Dietary Glycemic Index on Beta-cell Function
The study will determine if increasing the highs and lows of blood glucose levels (glycemic variability) impairs insulin secretion in people with impaired glucose tolerance and/or impaired fasting glucose who are at risk for…
- Conditions
- Impaired Glucose Tolerance, Oxidative Stress, Prediabetes, Impaired Fasting Glucose
- Trial name
- GIdiet (NCT01386645)
- Testing
- low glycemic index (LGI) diet, high glycemic index diet plus N-acetylcysteine
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Cognitive Decline, Dementia
Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults
This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults.
- Conditions
- Cognitive Decline, Dementia, Alzheimer's Disease, Mild Cognitive Impairment
- Trial name
- NCT01264614
- Testing
- Strengthening exercise
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Union College, New York
Mild Cognitive Impairment (MCI)
Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
This research is being done to find out if daily use of the drug levetiracetam can improve memory function in individuals with memory problems like those associated with Mild Cognitive Impairment (MCI) and Alzheimer's disease…
- Trial name
- NCT01044758
- Testing
- Levetiracetam 62.5mg, Levetiracetam 125mg, Levetiracetam 250mg
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University