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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT03182595 |
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Date of registration:
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25/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults
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Scientific title:
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Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults |
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Date of first enrolment:
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March 17, 2017 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03182595 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Natália Marto, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital da Luz |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Paracetamol
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Primary Outcome(s)
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- 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)
[Time Frame: 9 months]
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Secondary Outcome(s)
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Association between PSI and SULT1A1 genotype (optional).
[Time Frame: 9 months]
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Association between SULT1A1 genotype and SULT1A1 expression (optional);
[Time Frame: 9 months]
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Reproductibility, sensitivity and accuracy of the HPLC method (human samples will be used to validate the method);
[Time Frame: 9 months]
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Relationship between SULTA1 expression and predose and postdose metabolic profiles;
[Time Frame: 9 months]
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Relationships between PSI and subject characteristics (gender, age, genotype, smoking status, caffeine consumption, alcohol consumption, oral contraceptive use);
[Time Frame: 9 months]
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Secondary ID(s)
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HLUZ_001_2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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