6 results
The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
Primary objective: To reduce clinically relevant respiratory tract infections (including COVID-19) ind community dwelling older persons during the pandemic of SARS-CoV-2. Secondary objective: To reduce disease severity, the duration of hospital…
Cohorts A nd B :The primary objective is to evaluate the objective response rate (ORR) in patients with solid tumors harboring FGFRrearrangements or gastric cancer (including GEJ cancer) harboring FGFR2 amplifications based on independent central…
Phase 1 Dose Escalation:Phase 1 Dose Escalation has been completed as of Amendment 6Phase 1 Expansion Primary• To evaluate ORR in cholangiocarcinoma (intra-hepatic [iCCA] or extra-hepatic [eCCA]) patients with tumors harboring FGFR2 gene fusions or…
Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of COVID19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic…