12 results
Primary Objectives(1) investigate the safety and tolerability of JNJ-54175446 after multiple consecutive dose administrations;(2) investigate the plasma pharmacokinetics of JNJ-54175446 following multiple dose administration in healthy male subjects…
This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in…
Primary objectives:The primary aims of this study are to explore the relation of the extent of VS dopamine release and amphetamine-induced behavioral responses and to characterize the PD effect of repeat-dose amphetamine in healthy subjects.…
To assess the effects of dexamphetamine with and without alcohol on simulated driving performance.
Aim of the study is to investigate what the influence is of insomnia on driving performance and to what extent this influence is attenuated by the use of hypnotics. Therefore, over-the-road driving performance of treated and untreated patients…
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
The main objective of this study is to determine the release profile of the dexamphetamine sustained release tablets in vivo in humans. Depending on the results, the tablets might be candidates for use in the therapy of attention deficit…
Primary objective: To investigate whether either melatonin or temazepam is superior to placebo in improving subjective sleep quality and to investigate whether melatonin is non-inferior to temazepam in acute hospitalized older patients.Secondary…
The primary objective of the study is to evaluate the efficacy of treatment with AG-348, as assessed by the reduction in transfusion burden.Secondary: The secondary objective of this study is to evaluate the safety of treatment with AG 348.
Primary:• To evaluate the efficacy of treatment with AG-348 compared with placebo in increasing hemoglobin (Hb) concentrationsSecondary:• To evaluate the safety of AG-348• To determine the effect of the study treatment regimens on markers of…
Objectives: Primary:• To evaluate the long-term safety and tolerability of AG-348Secondary:• To evaluate the long-term efficacy of AG-348• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously…
To study the safety and efficacy of mitapivat in the treatment of adult subjects with sickle cell disease.