8 results
Primary objective:- To evaluate the safety and tolerability profiles of three oral doses of Namisol® in a healthy elderly population Secondary objective:- To evaluate the relationship between the pharmacodynamic effects (using VAS-feeling high, TAP-…
The primary objective of the study is to determine concentration of circulation cytokines na administration of LPS in the presence of iron sucrose (Venofer®), Deferasirox (Exjade®) of placebo.
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
Primary:- To investigate the modulatory effect profile of single doses of oral CBD on THC-induced effects in healthy volunteers.Secondary:- To assess the analgesic effect of a single dose of THC in healthy volunteers measured with the PainCart test…
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…