57 results
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of tosedostat added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…
- To evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations…
Primary ObjectiveTo evaluate and compare the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites MK-5172, and MK-8742 following administration of three test premarket…
The primary purpose of the study is to investigate how quickly and to what extent traces of metals that are naturally present in Smecta® could be absorbed and eliminated from the body (this is called pharmacokinetics). For exploratory purposes, the…
- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…
Primary objective:- To evaluate safety and tolerability of LRX712 after a single i.a. injection in OA patients.Secondary objective: - To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma.Exploratory objectives:- To evaluate LRX712 and…
The purpose of this study is to investigate how safe the new compound JHL1922 is when it is administered to healthy subjects. JHL1922 has not been administered to humans before, but it has been previously tested in the laboratory. In this study, the…
Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…
To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.
FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…
Primary Objective- To determine safety and tolerability of a single dose of ZW800-1 in healthy volunteers.Secondary Objectives- To determine the pharmacokinetics of a single dose of ZW800-1 by measuring the fluorescence of blood and urine.- To…
Primary ObjectivesTo assess the efficacy of 0.13mg/kg EMI-137 IV injection to detect lesions during colonoscopy, in subjects at high suspicion of developing colorectal cancer by:- Comparing the number of pathological lesions detected with WL with…
Primary Objective• To evaluate the local safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 consecutive days on wounded skin of healthy volunteers. Secondary Objectives• To evaluate the systemic safety…
Primary Objectives1. To assess pruritus and rash after administration of Neublastin or placebo in healthy subjects and migraine patients (Parts A and B)2. To assess headache and other migraine-associated symptoms after administration of Neublastin…
Primary ObjectivesTo evaluate the safety and tolerability of AP30663 in healthy males at doses up to 12mg/kgExploratory ObjectiveTo evaluate the effect of AP30663 on electrocardiographical parameters.
* To evaluate the effect of EDP1815 on the systemic immune system.* To evaluate the safety and tolerability of EDP1815 in multiple formulations.
The overarching goal of this study is to improve adequate resection of oral cancer. We will perform a clinical trial to determine the optimal dose of cRGD-ZW800-1 and to investigate the feasibility of intraoperative FLI to adequately assess tumor…