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Healthy Volunteers clinical trials

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NCT ID: NCT06311786 Not yet recruiting - Healthy Volunteer Clinical Trials

A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants

Mass Balance
Start date: April 9, 2024
Phase: Phase 1
Study type: Interventional

The main goal of this study is to learn how [14C]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants.

NCT ID: NCT06308068 Not yet recruiting - Healthy Volunteer Clinical Trials

Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers

Start date: July 30, 2024
Phase: Phase 1
Study type: Interventional

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 fed conditions

NCT ID: NCT06304740 Recruiting - Healthy Volunteers Clinical Trials

Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants

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

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

NCT ID: NCT06300580 Not yet recruiting - Healthy Volunteers Clinical Trials

Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers

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

The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer [11C]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects. ABBV-932 is a prodrug of DCAR (desmethyl-cariprazine), which is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom. Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days. Participants will be confined for approximately 15 days. Participants will receive 3 [11C]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed.

NCT ID: NCT06299410 Not yet recruiting - Healthy Volunteers Clinical Trials

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

Start date: March 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.

NCT ID: NCT06293326 Not yet 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 Not yet 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 Not yet recruiting - Healthy Volunteers Clinical Trials

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

Start date: March 26, 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 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study of VRG50635 in Healthy Volunteers

Start date: February 28, 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.