31 results
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…
- 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 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…
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…
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…
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…
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.…
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,…
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 investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…
- 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…
Primary Objective:Assess the safety and explore the biologically effective dose (BED) and/or the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of AZD4573 in patients with relapsed or refractory haematological…
In this study, we will investigate how quickly and to what extent the investigational medicinal product pritelivir is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). In addition, we will evaluate a possible…
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 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…
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…
To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems