58 results
The primary objective is to assess the feasibility of administering adjuvant S-1 and oxaliplatin in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy
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 objectiveTo evaluate if tralokinumab after 14 weeks of treatment (at steady state) changes the metabolism of substrates of CYP 1A2, 2C9, 2C19, 2D6, or 3A4 pathways in subjects with moderate-tosevere atopic dermatitisSecondary objectivesTo…
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 objectivesPart 1To evaluate the single dose safety and tolerability of donepezil 10 mg when administered with placebo, glycopyrrolate or trospiumPart 2To evaluate the safety and tolerability of donepezil when given with concomitant placebo,…
Benepali® and Brenzys® are approved as drugs that are administered as a subcutaneous (under the skin) injection using a pre-filled syringe. With a pre-filled syringe the drug is delivered through a needle which is inserted manually into the skin.…
The purpose of the study is to investigate how quickly and to what extent JZP-507 is absorbed and eliminated from the body (this is called pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If the results show that 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…
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…
The primary objective of this study is as follows: -To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14The secondary objective of this study is as follows: - To…
The primary objective of this study is to assess the pharmacokinetics and the effect of food on the pharmacokinetics of the YTX-7739 tablet formulation following single oral doses of 30 mg in HVs and to compare the relative bioavailability of the…
The purpose of this study is to provide remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is as follows: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with…
Primary:- To evaluate the safety and tolerability of NT-0167 in healthy volunteersSecondary:- To evaluate the pharmacokinetic (PK) profile of NT-0167 in healthy volunteers after the administration of single ascending (SAD) and multiple ascending…
The purpose of this study is to investigate the effect of the study compound efgartigimod on the immune system's response to vaccination with Pneumovax 23. We also investigate how safe efgartigimod is and how well it is tolerated when it is…
The purpose of the study is to investigate the effect of cedazuridine on the values of specific electrocardiogram (ECG) parameters. One of these parameters is the QT -interval. The QT -interval indicates the recovery time of the heart muscle cells…
The main purpose of this study is to investigate the effect of multiple doses of PHA-022121 on how quickly and to what extent a drug cocktail (a combination of agents consisting of caffeine, omeprazole, and midazolam) is absorbed, distributed,…
The purpose of this study is to compare administration of efgartigimod under the skin (subcutaneously/SC) to administration directly into a blood vessel (intravenously/IV). This is being studied to compare if subcutaneous injection is equally safe…
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…