Variability of Sulfotransferase Activity in Humans: an Approach to Improve Predictive Drug Response Part II: Analysis of Interindividual Variation in Hypertensive Patients

NCT06782204 | Completed Phase 1

• 1 other identifier: HL_001_2019 v1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, single center, nonrandomized clinical study in hypertensive patients, with intervention, over a 5-week period. After written informed consent, subjects will undergo screening evaluations, including blood and urine sampling (Visit 1). After visit 1, subjects who meet the selection criteria will enter a run-in period where they will receive paracetamol 1g tablet and collect blood and urine samples 2 hours afterwards (visit 2). A final visit for safety assessment will take place at week 5 (visit 3). Blood and urine samples will be used to quantify paracetamol and its metabolites.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  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)

  6 months

Secondary Outcomes (1)

• Secondary Outcome Measures

  6 months

Study Arms (1)

Single Arm

OTHER

At visit 2, complying subjects will receive a tablet containing 1 gram of paracetamol and have blood and urine samples collected 2 hours after administration.

Drug: Paracetamol

Interventions

Paracetamol DRUG

At visit 2, complying subjects will receive a tablet containing 1 gram of paracetamol and have blood and urine samples collected 2 hours after administration.

Single Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed of the nature of the study and giving written informed consent before any study assessment is performed,
• Able to understand and communicate effectively with study personnel,
• Male or non-pregnant, non-lactating female patients over 18 years of age,
• A diagnosis of hypertension defined either as:
• In untreated patients: office systolic blood pressure values \>= 140 mmHg and/ or diastolic blood pressure values \>= 90 mmHg,(Williams et al. 2018)
• Have no contraindication for 1 g of oral paracetamol.

You may not qualify if:

• Hypersensitivity or idiosyncratic reaction to paracetamol,
• Paracetamol intake in the last seven days before Visit 2,
• Non-steroidal antiinflammatory drug intake,
• Pregnancy or breastfeeding,
• BMI \<18 kg/m2,
• History of clinically significant liver disease or liver injury as indicated by abnormal liver enzymes such as ALT, GGT or serum bilirubin (any single parameter may not exceed 2x upper limit of normal),
• Current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study,
• Hospital da Luz employees, NMS\|FCM employees, medical students at NMS\|FCM and workers or others with a direct dependency on the PI or the sponsor,
• Participation in a clinical study of any investigational product 1 month prior to visit 1 or during the study.

Sponsors & Collaborators

• Hospital da Luz, Portugal: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

MeSH Terms

Conditions

Hypertension

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: July 1, 2020
• First Posted: January 17, 2025
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 17, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)