View clinical trials related to Healthy Volunteers.
Filter by:This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity. The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088: - Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood The study will have 3 treatment periods: Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088 Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic. Participants will visit the study clinic: - More than/at least once, within 2 to 28 days before the treatment starts - Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment - Once, within 7 to 10 days after they finish treatment for a health checkup During the study, the doctors and their study team will: - do physical examinations - collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088 - check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir
No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is: 1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration? With secondary aims : 1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation? 2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role? Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data: 1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED. 2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles. Background In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master's degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care. These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills. Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care.
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission. To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced. The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine - Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 2 treatment groups. In Group 1, participants will take: - BAY2927088 as a single dose on Days 1 and 8. - Itraconazole once daily on Days 5 to 11. In Group 2, participants will take: - BAY2927088 as a single dose on Days 1 and 14. - Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2. Participants will visit the study clinic: - at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study - on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2 - once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up During the study, the doctors and their study team will: - perform physical examinations - collect blood samples from the participants to measure the levels of BAY2927088 - check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
The purpose of this study is to measure brain exposure of [11C]savolitinib in healthy volunteers. This study will determine brain exposure of [11C]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of [11C]savolitinib. The second PET examination using [11C]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum [11C]savolitinib concentration in brain, partition coefficients between brain and plasma).