10 results
- To assess the effect of food (high-fat) on the bioavailability and pharmacokinetic (PK)- profile of a solid dosage formulation of JNJ-67953964.- To assess the effects of repeated QD administration of 200 mg of itraconazole (steady state) on the…
5.1 Study hypothesisThe primary study hypothesis states that oral treatment with itraconazole will reduce the epistaxis severity score (ESS) due to the anti-angiogenic effects of itraconazole.5.2 Research question and primary outcomeWhat is the…
Main objective: - Evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein (P-gp) inhibitor, on the safety and tolerability (including "thorough" electrocardiogram [ECG] assessment) and…
The objective of this study is to validate a novel MRS-based method to quantify NAD+ by selectively suppressing the coupled *-ATP spin system, which is overlapping with the NAD+/NADH signals in vivo. For NAD+/NADH quantification to be valuable in…
The purpose of this study is to investigate the effect of multiple doses of itraconazole on how quickly and to what extent the new compound PHA-022121 is absorbed into the body and eliminated from the body (this is called pharmacokinetics). It will…
The study will be performed in 2 cohorts, Cohort 1 and Cohort 2. In Cohort 1, it will be investigated what the effect is of itraconazole on how quickly and to what extent APX001 is absorbed and excreted by the body (this is called pharmacokinetics…
A non-inferiority/superiority trial was designed for the treatment of uncomplicated cystitis in the Dutch community, in which we compare a 1-day and 3-day regimen of FT to a 5-day regimen of nitrofurantoin to investigate the effect on time to…
This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1…
In this study we will look at how quickly and to what extent the study compound MEN1611 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics) and how this is influenced by the approved drug itraconazole fluvoxamine…
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…