429 Clinical Trials for Various Conditions
This study is being conducted to evaluate the safety and tolerability of single ascending and multiple ascending oral doses of NIP292 tablets administered following an overnight fast in healthy adult subjects.
A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers
The purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.
This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the infection starts in the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the toxin from doing damage to cells. This study is being conducted to see if Valortim given over 120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time after you receive the study medication) and Final Visit.
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the immune system does not identify part of the body as belonging to it. The immune system then destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the cells in the pancreas that produce insulin. Insulin is the hormone that "unlocks" the cells of the body. It allows glucose to enter and fuel them. Special cells in the body called islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The body's cells literally starve to death. Children are at risk of developing T1DM and the risk is much higher than other severe, chronic childhood diseases. The only treatments are a careful diet, planned physical activity, and testing blood sugar levels several times a day. The patient must also inject insulin each day or use an insulin pump. There is no cure for T1DM. Insulin injections are considered life support, because going without insulin for just a few days causes the blood to have too much acid in it and that can lead to death. On the other hand, taking too much insulin makes blood sugar levels go too low, and if untreated, can lead to death as well. DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM in the first place and it does not go away. The purpose of this study is to see how safe the study drug is. The study is also going to compare the levels of study drug in the blood and to measure the effect of the study drug on other substances in the blood that are linked to type 1 diabetes. These levels will be measured after the study drug is given as an injection under the skin and an injection into the vein. To date, Lisofylline has been tested when given as an injection in the vein. The investigators hypothesize that Lisofylline will be safe when given as an injection under the skin and in the vein and that levels of study drug will be very similar when given as an injection under the skin and in the vein. The investigators also hypothesize that Lisofylline will have a positive effect on the substances in the blood that are linked to type 1 diabetes.
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
The study will investigate whether GSK1362885 is safe and well-tolerated when administered to normal healthy subjects. The study will also measure blood levels of the study drug to determine how the body processes the drug (pharmacokinetics) and what effects the drug has on the body (pharmacodynamics).
The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that is intended to be used in the treatment of elevated levels of blood fats. This study will determine the way that 1-MNA is handled by the body, and will also determine its effect on commonly measured blood fat parameters.
The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements. Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.
Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens requires regular patient instruction, performance assessment, monitoring and general encouragement from healthcare staff. Exercise at home though convenient for patients is not conducive for provision of the professional support needed to maximize prescribed regimen effectiveness. Software in development by Reflexion Health Inc. along with the Naval Medical Center San Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for the designed software package tentatively called, "Reflexion." Kinect® contains a marker-less/controller-less motion tracking camera. The final Reflexion software will rely on a "Rehabilitation Measurement Tool (RMT)" to detect cardinal plane skeletal joint movement and its velocity utilizing the embedded Kinect® camera while also providing patient visual feedback via an avatar on a television screen. In this observational minimal risk study, RMT/Kinect® functional reliability and usability will be assessed. Twenty healthy subjects will physically set-up and turn-on the hardware/software system; receive exercise directions from the RMT; then conduct a series of knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair. An initial limited data set, obtained by Reflexion Health, provided validity and reliability measures. Eighteen degrees of absolute difference was detected between manual goniometry and Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise. Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A correctable systematic bias toward underestimation by the RMT will allow for future more accurate estimations of joint positioning improving face validity. RMT functional reliability and general usability will be expressed in this study utilizing descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect® camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software errors and failure will tallied and measured to ascertain RMT reliability. User-RMT interaction quality will be evaluated with video recordings of each set-up and exercise session. Specifically, usability measures will include: need for additional assistance setting-up or operating the RMT; number of attempts required by the subject to interact with a specific feature: time spent on specific elements during the session. Participant feedback will be elicited post-session using two scaled questionnaires: System Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide software modifications needed prior to implementation of future clinical studies within the NMCSD population.
More than one site will participate in the collection of blood and urine samples from healthy adult subjects. These samples will be used for future testing to serve as aged-matched normal controls and to establish normal reference ranges in the development of new invitro diagnostic devices.
The effect of rifampin on the pharmacokinetics of lurasidone
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal tablets in healthy adult volunteers.
This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of \[14C\]-TD-1473. Subjects in cohort 2 will receive a single oral dose of \[14C\]-TD-1473 only.
The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of an investigational medication used to treat chronic obstructive pulmonary disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a 28 day washout period between each of the 2 dosing routes.
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C
This is a randomised, double-blind, single dose, parallel groups study to compare the PK, immunogenicity, and safety of 3 abatacept products (DRL_AB, RP and RMP) in male NHV.
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.