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Showing 1-20 of 257 trials
NCT07554365
AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4). As a potential new therapy for COPD, AN01 is expected to serve either as a monotherapy for COPD or as adjunctive therapy to current inhaled standard treatments, potentially generating synergistic complementary effects in patients requiring additional therapeutic options. The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of AN01 in healthy participants.
NCT07231744
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
NCT07546201
The aim of this study is to compare the motor imagery abilities of patients with migraine to those of healthy individuals, and to examine the relationship between motor imagery and proprioception (cervical and trunk), balance, body awareness, anxiety, and depression levels. Additionally, the study aims to investigate the relationship between proprioception and balance in patients with migraine. Motor imagery abilities of patients with migraine and healthy control subjects (aged 18-65 years; planned sample size: 68 individuals in each group, 68 migraine patients and 68 healthy participants) will be assessed using the Movement Imagery Questionnaire-3, the Motor Imagery Ability Test, mental chronometry, mental rotation tasks, and functional MRI (fMRI) during motor imagery of different tasks. Additionally, in patients with migraine, cervical and trunk proprioception, balance, body awareness, the Tampa Scale for Kinesiophobia, the Vertigo Symptom Scale, the Dizziness Handicap Inventory, and the Hospital Anxiety and Depression Scale will be evaluated. 1. Hypothesis H0: There is no difference in motor imagery abilities between patients with migraine and healthy controls. H1: There is a difference in motor imagery abilities between patients with migraine and healthy controls. 2. Hypothesis H0: There is no relationship between motor imagery abilities and proprioception in patients with migraine. H1: There is a relationship between motor imagery abilities and proprioception in patients with migraine. 3. Hypothesis H0: There is no relationship between proprioception (cervical/trunk) and balance in patients with migraine. H1: There is a relationship between proprioception (cervical/trunk) and balance in patients with migraine. 4. Hypothesis H0: There is no relationship between motor imagery abilities and body awareness, anxiety, and depression in patients with migraine. H1: There is a relationship between motor imagery abilities and body awareness, anxiety, and depression in patients with migraine.
NCT07339735
The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.
NCT07401472
Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants
NCT07517289
An Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar 40mg/0.4ml with that from the Reference IMP, Clexane® (40 mg/0.4ml), Following Single-Dose Administration in Healthy Participants. Test: Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt. Reference: Clexane (Enoxaparin Sodium 40mg/0.4ml) manufactured by Sanofi Aventis, Egypt. Primary objective: To assess biosimilarity between a single dose from the test product versus the reference product in healthy participants Secondary objective: To investigate the safety and tolerability of the formulations. This study is a randomized single-dose, two-way, two-period, two-sequence, crossover biosimilarity study with a washout period of one week after each dosing.A minimum of 21 healthy adult male and female participants from Egyptian population will be enrolled in this study, along with 5 additional participants to account for potential dropouts or withdrawal. 26 Participants plus 1-4 alternates will be admitted to the study. An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration. Withdrawals after study drug administration will not be replaced. All participants will be healthy adults aged (21-55) years, with a BMI within the accepted range of 18.5-30 kg/m², and will meet the study's selection criteria.
NCT06693765
A study to investigate the pharmacokinetics, safety, and tolerability of AZD4144 in participants with severe renal impairment, end-stage kidney disease, and in healthy participants.
NCT06709820
The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants. Study participation may last up to 22 weeks and up to approximately 18 study visits.
NCT07508501
This study is a single-center, randomized, open-label, two-period crossover design to evaluate the effect of food on the pharmacokinetic profile of ammoxetine hydrochloride enteric-coated tablets.
NCT06385119
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts: Part A * The effect of food on the single dose PK of plixorafenib administered with cobicistat. * The effect of cobicistat administration on the single dose PK of plixorafenib. * The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants. Part B * To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone. * To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat. * To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.
NCT07310901
This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body. The study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood. Part 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given. Participants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.
NCT06988423
This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.
NCT06342713
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
NCT07476469
This study investigates if anhedonia and anxiety symptoms are associated with alterations in reinforcement learning, effort trade-offs for wins vs. punishments, and foraging behavior under threat. Moreover, it will investigate whether these processes can be influenced by a metabolic load and/or transcutaneous vagus nerve stimulation (tVNS). The project consists of (a) an online reinforcement learning study, used to characterize learning, reward sensitivity, and meta-cognition, and (b) a laboratory study in which participants first undergo fMRI while completing an effort-based decision-making task. Second, participants will complete two sessions in VR with randomized active or sham tVNS during a foraging task before and after a caloric load with concurrent physiological recordings.
NCT07471204
Knee osteoarthritis (OA) is a degenerative joint disease characterized by pain, muscle weakness, and functional limitations that significantly affect lower limb muscle performance. Structural and physiological alterations in the quadriceps muscle, particularly in the vastus medialis obliquus (VMO), have been reported in individuals with knee OA, including reductions in muscle cross-sectional area, intramuscular fat infiltration, vascular changes, and impaired neuromuscular activation. Muscle oxygenation (SmO₂) is an objective indicator of the metabolic status and circulatory capacity of skeletal muscle. However, the oxygenation dynamics of the quadriceps muscle before and after exercise in individuals with knee OA have not been sufficiently investigated. The aim of this study is to evaluate VMO muscle oxygenation at rest, during exercise, and during the recovery period in individuals with knee OA and to compare these parameters with age- and sex-matched healthy individuals. In addition, the study will examine the relationship between muscle oxygenation parameters, muscle strength, functional performance, and pain levels. Understanding these physiological responses may provide insight into the metabolic mechanisms underlying muscle dysfunction in knee OA and may contribute to the development of more individualized rehabilitation strategies.
NCT07364214
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi \[14C\] following a single IV infusion of \[14C\]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
NCT07444424
The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
NCT07025551
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
NCT07122765
The overarching aim of this research is to study the effects of caloric content and timing of meals on measures of postprandial metabolism and cardiovascular response 1. Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge. 2. Determine the effect of meal timing on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge. Hypothesis: 1) that hypercaloric meals will result in significantly reduced indices of metabolic flexibility and pulse wave analysis as compared to eucaloric meals and 2) eucaloric meals consumed later in the day will result in significantly reduced metabolic flexibility and pulse wave analysis as compared to eucaloric meals consumed in the morning.
NCT07433543
Foam rolling (FR) is a technique involving the application of external pressure to muscles and connective tissues using different devices (e.g. foam rollers, massage rollers, balls, etc.) , with the aim of reducing muscle tension, soreness, and stiffness, and improving circulation, and flexibility. Emerging evidence suggests that FR may also enhance tissue perfusion and blood flow and could induce a relaxation response, potentially modulating autonomic balance toward increased parasympathetic activity. The cervical region is of particular interest due to the presence of clinically relevant vascular structures, such as the carotid arteries, whose mechanical stimulation may elicit cardiovascular responses. Accordingly, the present study was designed to investigate the acute effects of cervical foam rolling on blood pressure, while simultaneously examining tissue hardness and heart rate variability as potential underlying mediators, and to explore a possible dose-response relationship between foam rolling volume and blood pressure through an inter-set analysis. Additionally, the acute effects of cervical foam rolling on local range of movement were also investigated.