6 results
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…
Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.
To determine the ratio of parent drug to metabolites in the circulation.Profiling of [14C]-etripamil metabolites in blood, urine and feces.To determine the mass balance of drug-related materials following intranasal administration.To determine the…
The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF.