6 results
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
In this study, we will investigate the influence of the amino acid L-arginine, which enhances release of nitric oxide in the body, on BAT activity and metabolism in healthy subjects with overweight. This will increase understanding on the effect of…
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
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…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
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…