8 results
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…
The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of ACT-246475. Furthermore, the safety and tolerability of ACT-246475 when administered after administration of rifampicin, will…
The purpose of this study is to investigate how safe the new compound JHL1922 is when it is administered to healthy subjects. JHL1922 has not been administered to humans before, but it has been previously tested in the laboratory. In this study, the…
Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…
* To evaluate the effect of EDP1815 on the systemic immune system.* To evaluate the safety and tolerability of EDP1815 in multiple formulations.
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…
The objectives of this exploratory study are: * To evaluate the safety and local tolerability of the new flurbiprofen 8.75 mg spray. * To compare the pharmacokinetic profile of the new flurbiprofen 8.75 mg spray to marketed flurbiprofen 8.75 mg…
Primary Objectives: - To evaluate the safety in mother and neonate/infant of nipocalimab administered to pregnant women at high risk for EOS-HDFN. - To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or…