View clinical trials related to Healthy Volunteers.
Filter by: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).
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening.
This study is the first-in-human (FIH) study for 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. Study details include: - The study duration will be up to 16 months. - The treatment duration will be up to 14 days. - Safety follow-up 30 days after last dose of study drug.
This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: - Screening: up to 4 weeks - Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. - Washout: One day washout is planned after each treatment period hence providing 2 days between doses. - Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.
The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers
The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated.
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions