NCT03182595

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

Completed Phase 1 Last updated 25 August 2021

What this trial tests

Phase 1 trial testing Paracetamol in Healthy Volunteers in 36 participants. Completed in 31 December 2018.

Timeline

17 March 2017

Primary endpoint
31 January 2018

31 December 2018

Quick facts

Lead sponsor	Hospital da Luz, Portugal
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	36
Start date	17 March 2017
Primary completion	31 January 2018
Estimated completion	31 December 2018
Sites	1 location across Portugal

Drugs / interventions tested

• Paracetamol (Paracetamol) — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Hospital da Luz, Portugal

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A simple method to measure sulfonation in man using paracetamol as probe drug.
   Marto N, Morello J, Antunes AMM, Azeredo S, et al · · 2021 · cited 5× · PMID 33907224 · DOI 10.1038/s41598-021-88393-3