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Healthy Volunteers clinical trials

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NCT ID: NCT06348355 Recruiting - Healthy Volunteers Clinical Trials

A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

Start date: April 12, 2024
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT06344065 Recruiting - Healthy Volunteers Clinical Trials

Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.

NCT ID: NCT06342713 Recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Start date: June 3, 2024
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT06336005 Recruiting - Healthy Volunteers Clinical Trials

A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People

Start date: March 28, 2024
Phase: Phase 1
Study type: Interventional

The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine. Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors. The study will last for about 10 months in total.

NCT ID: NCT06335134 Recruiting - Healthy Volunteers Clinical Trials

A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

Start date: July 14, 2023
Phase: Phase 1
Study type: Interventional

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

NCT ID: NCT06329895 Recruiting - Healthy Volunteers Clinical Trials

A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

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 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. Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood. The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088: - Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of the drug in participants' blood In this study, participants will take the following treatments: - Dabigatran in the morning of Day 1 and 9. - Rosuvastatin in the morning of Day 3 and 12. - BAY2927088 two times a day in the morning and evening of Days 6 to 15. Participants will be in this study for about 8 weeks with 3 visits to the study clinic. Participants will visit the study clinic: - at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study - once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment - once, 7 to 10 days after last dose of BAY2927088, for a health check-up During the study, the doctors and their study team will: - do physical examinations - collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin 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. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06326606 Recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants

Start date: March 27, 2024
Phase: Phase 1
Study type: Interventional

MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants.

NCT ID: NCT06320106 Recruiting - Healthy Volunteers Clinical Trials

Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives.

NCT ID: NCT06314880 Recruiting - Healthy Volunteers Clinical Trials

Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)

Start date: July 22, 2023
Phase: Phase 1
Study type: Interventional

The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.

NCT ID: NCT06299410 Recruiting - Healthy Volunteers Clinical Trials

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.