drugset / Trial / NCT03863366

Effects of Acute Prucalopride Administration in Healthy Volunteers

NCT03863366

Completed 41 enrolled University of Oxford
RandomizedParallel-groupTriple-blindBasic science

Summary

This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive a single dose of either prucalopride (1mg) or placebo. All participants will come for a Screening Visit to ensure their suitability for the study. If they meet study criteria, they will be invited to a Research Visit, where they will receive the study medication and wait for two hours while the drug reaches peak levels. After two hours they will be asked to complete a series of computer-based tasks measuring emotional, non-emotional cognitive processing, and reward processing. The primary study hypothesis is that acute prucalopride administration will have positive effects on processing facial expressions of emotion. Secondary hypotheses are that acute prucalopride administration will affect other measures of emotional processing, and non-emotional cognition.

Timeline

Start
2017-02-07
Primary completion
2017-08-08
Completion
2017-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Prucalopride Small molecule 1 mg

Indications