NCT03182595

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

May 25, 2017

Last Update Submit

August 24, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • - Coefficient of variation of paracetamol sulfonation index (PSI), a ratio between the measured plasma concentrations of paracetamol sulfate (PS) and PS+ paracetamol glucoronide (PG) + paracetamol (P)

    9 months

Secondary Outcomes (5)

  • Reproductibility, sensitivity and accuracy of the HPLC method (human samples will be used to validate the method);

    9 months

  • Relationships between PSI and subject characteristics (gender, age, genotype, smoking status, caffeine consumption, alcohol consumption, oral contraceptive use);

    9 months

  • Relationship between SULTA1 expression and predose and postdose metabolic profiles;

    9 months

  • Association between SULT1A1 genotype and SULT1A1 expression (optional);

    9 months

  • Association between PSI and SULT1A1 genotype (optional).

    9 months

Study Arms (1)

open---label

EXPERIMENTAL

An open---label, single centre, nonrandomized clinical study in healthy volunteers, with intervention over a 13---week period.

Drug: Paracetamol

Interventions

ParacetamolDRUG

Volunteers will be screened at visit 1, and if they meet the inclusion/exclusion criteria they will receive the intervention at visit 2. At visit 2, complying subjects will receive a tablet containing 1 gram of paracetamol and have a blood sample collected 2 hours after administration; these procedures will be repeated on 2 more occasions (visits 3 and 4). The subjects will come for 5 visits during the study. Visit 1 and 2 must occur within 7 days of each other, visits 2, 3 and 4 will be four weeks (± 3 days) apart and visit 5 scheduled four weeks (± 3 days) after visit 4.

open---label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females, over 18 years of age,
  • Informed of the nature of the study and giving written informed consent,
  • Report no significant diseases during screening,
  • Have normal CBC, renal function and liver enzymology,
  • Have no contraindication for paracetamol,
  • Be on no regular medical treatment, except for contraceptives,
  • Be able to communicate effectively with study personnel.

You may not qualify if:

  • Hypersensitivity or idiosyncratic reaction to paracetamol,
  • Intake of any medication, except for contraceptives, within 14 days before start of the study,
  • Pregnancy or breastfeeding,
  • BMI \<18 kg/m2,
  • Participation in a clinical study of any investigational product 1 month prior to visit 1 or during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Related Publications (1)

  • Marto N, Morello J, Antunes AMM, Azeredo S, Monteiro EC, Pereira SA. A simple method to measure sulfonation in man using paracetamol as probe drug. Sci Rep. 2021 Apr 27;11(1):9036. doi: 10.1038/s41598-021-88393-3.

    PMID: 33907224DERIVED

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Natália Marto, MD

    Hospital da Luz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 9, 2017

Study Start

March 17, 2017

Primary Completion

January 31, 2018

Study Completion

December 31, 2018

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)