57 Clinical Trials for Various Conditions
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array application to the skin. Part II will be a randomized study in which doxorubicin-containing arrays will be applied to subjects demonstrated by biopsy to have basal cell cancer. A subject will be randomized to one of four dose groups: placebo microneedle array and 50 µg, 100 µg, and 200 µg doses of doxorubicin in a tip-loaded, dissolvable microneedle arrays (D-MNA).
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans
Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.
The purpose of the first part of this study is to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects. The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 in healthy normal volunteers Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in patients with major depressive disorder
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors (Part B).
The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.
This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly itraconazole in Part B). In Part A, the objective is to assess the effects of repeated administration of EES as CYP3A4 inhibitor, on the PK profile of a single oral dose of SAR443820 tablet in healthy male and female participants. In Part B, the objective is to assess the effects of repeated administration of itraconazole on the PK profile of a single oral dose of SAR443820 capsule in healthy male participants. Part A includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + EES). Part B includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + itraconazole). The washout period between single SAR443820 administration in Period 1 and the start of dosing with EES (Part A) or itraconazole (Part B) in Period 2 is at least 4 days. The study duration is approximately 7 weeks for each Part A and Part B. The treatment duration is: * For SAR443820 (both Part A and Part B): 1 day in each Period; single dose of SAR443830 on Period 1 (P1)-Day 1 and on Period 2 (P2)-Day 6 for each Part. * For EES (Part A): 9 days of treatment in Period 2 with P2-Day 1 starting at least 4 days after P1-Day 1. * For itraconazole (Part B): the treatment duration lasts 11 days in Period 2 and it is fixed once the results of Part A are issued, P2-Day 1 starting at least 4 days after P1-Day 1.
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted \[RC\] and high shear wet granulation \[HSWG\]) compared to the reference capsule formulation under fasted conditions. This is a 3-period; cross-over study that will guide which gepotidacin formulation will be used for future studies. Following review of pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed with Parts 1b and 2. Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will be evaluated under fasted conditions. The duration of the study (from Screening to the Follow-up visit) will be approximately 44 days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3 treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12 Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.
Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.
Using a pragmatic cluster randomized trial, this study aims to examine the feasibility, and acceptability of a 3-week behavioral sleep intervention, Sleep Well, Bee Well (SWBW), and to test the preliminary efficacy of SWBW compared to a wait-list control with children ages 1-2.5 years old at two Early Head Start (EHS) centers on toddler sleep characteristics and parent wellbeing.
This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2 sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares the blinded individual treatments from open-label supplies). The study programmer and statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded for both parts of the study.
The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.
This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs). In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period. In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period. The 2 parts may be conducted in parallel.
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects. This is a 2-treatment, 2-period crossover study with approximately up to 28 healthy subjects, with screening procedures within 28 days of enrolment. Part 2: This is a Phase 2a, single-blind, placebo run-in, multiple-dose safety study to evaluate the safety, tolerability, and PK of LQT-1213 in patients diagnosed with LQT1, LQT2 or LQT3. Up to 12 participants with LQT1, up to 20 participants with LQT2 and up to 12 participants with LQT3 will be recruited.
Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions. Two treatments are as follows: * Treatment A: SAR443820 - tablet formulation in fasted condition * Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Part 2: This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation. Two treatments are as follows: * Treatment C: SAR443820 - tablet formulation in fasted condition * Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Participants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.
The goal of Parts A and B of this Phase 1, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy participants. In Part C, the goal is to evaluate the differences in bioavailability between a tablet and suspension formulation of JNT-517 and the food effect in healthy volunteers. All participants in Part C will receive JNT-517. The goal of Part D is to assess the safety, tolerability, PK, and effect on urinary Phe and other amino acids of JNT-517 in participants with phenylketonuria (PKU). Participants in Part D will receive either JNT-517 or placebo and will be blinded to their treatment assignment. The study consists of 4 parts: * Part A: SAD in healthy participants -randomized, double-blind, placebo-controlled * Part B: MAD in healthy participants (14 days)-randomized, double-blind, placebo-controlled * Part C: Relative bioavailability of 2 formulations and food effect in healthy participants-randomized, open-label * Part D: Phase 1b in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety.
The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.
The primary objective will be to study changes in putamen connectivity and depression severity in depressed teens with meditation training. H1: Putamen node strength will increase in the training group compared to the active controls. H2: This increase in node strength will correlate with practice amount recorded by participants. H3: There will be a significant reduction in self-rated depression symptoms following the training as measured by the Reynolds Adolescent Depression Scale (RADS-2), compared to controls. H4: This reduction will correlate with the increase in putamen node strength. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, active-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action \[TARA\]) on the primary outcome (Putamen structural node strength) and secondary outcome (depression symptoms measured using Reynolds Adolescent Depression Scale \[RADS-2\]) in depressed adolescents between the ages of 14 to 18 years old.
This study will assess the safety, tolerability, and pharmacokinetic (PK) of AZD5462 following single ascending dose (SAD) and multiple ascending dose (MAD) administration in healthy male and female participants and healthy participants of Japanese descent.
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.