View clinical trials related to Healthy Volunteers.
Filter by:Primary Objectives: - To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-venglustat. - To determine the pharmacokinetics (PK) of venglustat and its contribution to the overall exposure of radioactivity. - To determine the metabolic pathways, metabolite profile, chemical structures and main excretion route of the main venglustat metabolites and the metabolite contribution to the overall exposure of radioactivity. Secondary Objective: To assess the clinical and biological tolerability of oral solution of venglustat
This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administered to that group may be higher than a previous dose shown to be safe in other participants. The study is also designed to determine blood levels of VEL-101 and some substances produced by the immune system following VEL-101 administration. This information can provide insight into how quickly VEL-101 is eliminated from the body and some if its effects on the body.
The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.
A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.
The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.
The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different ethnic groups, after single and multiple doses of BIIB122. Researchers also want to see if single and multiple doses of BIIB122 are safe and if healthy participants can tolerate given doses of BIIB122.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in. The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks. The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who: - Must be male or female of 18 to 75 years of age, inclusive at the time of the study. - Are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. - Have a BMI (body mass index) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb). - Are capable of giving signed informed consent document. All participants in this study will receive Lorlatinib. Participants will be placed into 1 of 3 cohorts based on their hepatic (liver) function. Participants will take Lorlatinib once by mouth. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will take part in this study for up to 35 days.
ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This study is in healthy men. The main aim of this study is to learn how ASP0367 is processed by and acts upon the bodies of healthy men. To do this, [14C] which is a certain chemical (called a tracer, or radionuclide) has been added to ASP0367. [14C] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. [14C] will be picked up by a scanner and will be used to follow ASP0367 through the body. [14C]ASP0367 will be a liquid. During the study, the men who take part will stay in the clinic for 6 days and 5 nights. Some men may need to stay up to an extra 7 days in the clinic. This will happen if there is a medical reason or if they still have traces of radiation in their blood, urine or feces. On the day before they drink [14C]ASP0367, the men will be asked about their medical history, have a medical examination, and have their vital signs checked (blood pressure and pulse). They will also have an ECG to check their heart rhythm. They will give urine, stool and blood samples for laboratory tests. They will also be asked if they have had any medical problems. The men will fast for 10 hours or more before drinking [14C]ASP0367 and for 4 hours afterwards. They will only have one drink of [14C]ASP0367. They will need to lie still for 4 hours after drinking [14C]ASP0367. They will have their vital signs checked and give urine, stool and blood samples for laboratory tests. Then, they will give urine, stool and blood samples every day until they leave the clinic. They will also be asked every day if they have had any medical problems. The day after they drink [14C]ASP0367, the men will also have an ECG. On the last clinic day, the men will also have a physical exam, have their vital signs checked and have an ECG. The men can leave the clinic once [14C]ASP0367 has left the body and they have no medical problems. About 10 days later, the clinic will call the men to check if there were any further medical problems. No other visits are planned during this study.
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.