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Healthy Volunteers clinical trials

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NCT ID: NCT06293326 Recruiting - Healthy Volunteers Clinical Trials

A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants

Start date: March 6, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus). Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release). In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body. The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time. For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time. The participants will be randomly (by chance) assigned to one of two treatment groups: Participants in the first group will take the treatments at night. Participants in the second group will take the treatments during the day. All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first. Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes: 1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study 2. visits for treatment with a gap of 6-8 days between each treatment, and 1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health. During the study, the doctors and their study team will: check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG) take images of the stomach at different times after taking the treatment measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach ask the participants questions about how easy it is to take the study treatment ask the participants 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 of whether they think it is related to the study treatment, or not. As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned.

NCT ID: NCT06291285 Recruiting - Healthy Volunteers Clinical Trials

A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

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

This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day.

NCT ID: NCT06290050 Completed - Healthy Volunteers Clinical Trials

A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

Start date: March 29, 2024
Phase: Phase 1
Study type: Interventional

The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).

NCT ID: NCT06286475 Recruiting - Healthy Volunteers Clinical Trials

A Study of VRG50635 in Healthy Volunteers

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.

NCT ID: NCT06286033 Recruiting - Healthy Volunteers Clinical Trials

A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants

Start date: February 20, 2024
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3.

NCT ID: NCT06284915 Recruiting - Healthy Volunteers Clinical Trials

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

Start date: March 19, 2024
Phase: Phase 3
Study type: Interventional

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

NCT ID: NCT06284902 Completed - Healthy Volunteers Clinical Trials

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

Start date: February 23, 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions.

NCT ID: NCT06281158 Completed - Healthy Volunteers Clinical Trials

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

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

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.

NCT ID: NCT06278766 Completed - Healthy Volunteer Clinical Trials

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration

Start date: February 21, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 in healthy, male volunteers following administration of a single oral dose.

NCT ID: NCT06274749 Recruiting - Healthy Volunteer Clinical Trials

Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial

Start date: June 26, 2024
Phase: N/A
Study type: Interventional

Background: As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose. Objective: To learn if UA improves levels of insulin and other hormones that help control blood glucose. Eligibility: People aged 55 years and older with a body mass index of 27 or higher. Design: Participants will have 6 clinic visits over 8 weeks. Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. Participants will have tests during the study including: Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours. Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study. Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces. Imaging scans of the thigh; scans of the brain are optional....