6 results
To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.
- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…
- To evaluate if co-administration of single-dose almorexant (200 mg) influences the psychomotor and cognitive impairing effects of ethanol (at a blood level of 0.6 g/L for 5 hours) in healthy subjects.-To evaluate the potential PK interactions…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…