7 results
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) will be increased by acute tryptophan depletion (ATD, a drink that decreases serotonin synthesis). In other words, we will…
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine (a cholinesterase inhibitor). Secondary, we will assess the effects of biperiden and…
• To determine the profile of CNS effects at several time points after 2 mg and 4 mg biperiden in comparison to placebo in healthy elderly subjects.• To investigate the safety and tolerability of biperiden in healthy elderly subjects.• To determine…
We will examine the cognitive performance of healthy young participants at different time points after a single administration of biperiden. The behavioural outcomes and electrophysiological correlates will be linked with the serum levels of…
- Characterization of the CNS PD profile of IV administered biperiden- Characterization of the pharmacokinetic profile of IV administered biperiden- To confirm the plasma concentration-effect relationship of biperiden using population PK-PD modeling…