12 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary objective: - To determine the feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to identify dysplasia and/or malignant lesions in patients with Barrett*s esophagus. - To evaluate the safety of EMI-…
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
The primary objective of this study is to determine the safety and feasibility of fluorescence molecular endoscopy using the fluorescent tracer bevacizumab-800CW for identification of pathological complete response after neoadjuvant…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get insight in the PD-L1 expression before and after neoadjuvant therapy in…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
Primary:To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in…
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…
Primary Objective: to assess the feasibility of the use of BabyCheck combined with standard PO for infants < six months of age presented at the emergency GP post. Secondary Objective(s): 1. To assess the sensitivity and specificity of the…