Clinical trials: Functional Impairment
Anesthesia
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.
- Trial name
- NCT00702715
- Testing
- sugammadex
- Volunteers
- 69 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Mild Cognitive Impairment
A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK!
The goal of this study is to refine and test a strategy for engaging older adults with symptoms of SCD/MCI (subjective cognitive decline/mild cognitive impairment) as volunteers to help English language learners (ELLs) who live…
- Trial name
- NCT04717479
- Testing
- Intervention (videoconferencing)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Functional Impairment, Caregiving
Evaluation of Veteran-Directed Home and Community Based Services
Veteran-Directed Home and Community Based Services (VD-HCBS) is focused on preserving Veteran's independence and the VA Office of Geriatrics and Extended Care is planning an expansion of VD-HCBS to 90 additional VA Medical…
- Trial name
- VD-HCBS Eval (NCT03145818)
- Testing
- VD-HCBS
- Where
- 2 sites in United States
- Volunteers
- 126 people
- Sponsor
- VA Office of Research and Development
Infectious Disease
A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)
This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single 125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin) will be determined in participants with…
- Trial name
- NCT01275170
- Testing
- MK-7655, Imipenem + Cilastatin, Caffeine
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06568861
- Testing
- ALG-097558
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Pneumonia
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).
- Trial name
- NCT00759564
- Testing
- CP-70,429 and PF-03709270
- Where
- 2 sites in United States, Belgium
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Atrial Fibrillation
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
- Trial name
- NCT01896297
- Testing
- Pradaxa, dabigatran etexilate
- Where
- 26 sites in United States
- Volunteers
- 63 people
- Sponsor
- Boehringer Ingelheim
Rheumatoid Arthritis
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.
- Trial name
- NCT03417778
- Testing
- Filgotinib
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
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
Infections, Bacterial
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe…
- Trial name
- NCT03562117
- Testing
- Gepotidacin
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to…
- Trial name
- NCT01181986
- Testing
- Exenatide SC, Exenatide IV, Exendin-9
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Carl T. Hayden VA Medical Center
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
Hepatic Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01767103
- Testing
- Ferriprox®
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ApoPharma
ADHD Specifically With Executive Function Impairment
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function…
- Trial name
- NCT01101022
- Testing
- SPD489
- Where
- 39 sites in United States
- Volunteers
- 161 people
- Sponsor
- Shire
Mindfulness Training, Neurocognitive Function
Mindfulness Training, Mental Fatigue, Endurance Performance and Neurocognitive Functions
Mental fatigue has been suggested that would impair neurocognitive functions and sports performance. On the other hand, mindfulness training (MT) seems to as a promising approach to attenuate mental fatigue and counteract its…
- Conditions
- Mindfulness Training, Neurocognitive Function, Sports Performance, Mental Fatigue
- Trial name
- NCT05452460
- Testing
- Mindfulness intervention
- Where
- Taiwan
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- National Taiwan Normal University
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