drugset / Trial / NCT03182595

Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults

NCT03182595

NaSingle-groupOpen-labelBasic science

Summary

An open-label, single centre, nonrandomized clinical study in healthy volunteers, with intervention over a 13---week period. After written informed consent, subjects will undergo screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection criteria will enter a run---in period of 8 weeks where participants will receive paracetamol 1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit for safety assessment will take place at week 13 (visit 5). Blood samples will be used to quantify P, PG e PS.

Timeline

Start
2017-03-17
Primary completion
2018-01-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1 g

Indications

No indication recorded.