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Pharmacological assay model on the influence of the CYP2C9 gene mutation in anti-inflammatory drugs from saliva samples and their role in the prescription individualization

Pharmacokinetic/pharmacodynamic (PK/PD) model on the influence of P450 (CYP2C9) genetic polymorphism of non-steroidal anti-inflammatory drugs and major metabolites from saliva samples by LC MS/MS and their role in prescribing personalization

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-38jcm9
Enrollment
Unknown
Registered
2020-02-19
Start date
2019-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigation of cytochrome P450 polymorphisms, especially CYP2C9, and their role in the metabolism of non-steroidal anti-inflammatory drugs (NSAIDs).

Interventions

There will be 2 groups already outlined (mutated to CYP2C9 and not mutated) with 15 participants each. All participants go through 3 stages and each consists of administering a single dose of NSAIDs o
Drug

Sponsors

Faculdade de Odontologia de Bauru
Lead Sponsor
Faculdade de Odontologia de Bauru
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Good general health condition; absence of infection and inflammation; absence of systemic diseases; do not use any medicine that may alter the perception of pain or antidepressant, diuretic or anticoagulant medicines.

Exclusion criteria

Exclusion criteria: Patients with systemic diseases; patients with inflammation or infection; patients with a history of gastrointestinal bleeding or ulcerations; patients with cardiovascular, renal or liver disease; patients taking antidepressant, diuretic or anticoagulant medications; patients with a history of allergy to any other NSAIDs; pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Slower metabolization of non-steroidal anti-inflammatory drugs administered to individuals who have polymorphisms in the CYP2C9 gene compared to individuals without polymorphisms in CYP2C9. Metabolization will be assessed using mass spectrometry (LC MS/MS). Metabolization will be considered slower if it presents a statistical difference compared to the results of individuals without the polymorphism.

Secondary

MeasureTime frame
Correlate the slower metabolization of individuals with polymorphisms in the CYP2C9 gene and less effective action of NSAIDs in terms of controlling inflammatory signals. Analysis of mass spectrometer data (LC MS / MS) and relevant clinical signs and symptoms, observed or reported. Outcome will be obtained by comparing the two groups and statistically relevant results.;Greater involvement of adverse effects with continuous use of NSAIDs (due to slower metabolism) in individuals with the polymorphic genotype of the CYP2C9 gene compared to those with wild genotype. Analysis of mass spectrometer data (LC MS / MS) and relevant clinical signs and symptoms, observed or reported. Outcome will be obtained by comparing the two groups and statistically relevant results.

Countries

Brazil

Contacts

Public ContactAdriana Calvo

Faculdade de Odontologia de Bauru

dricalvo@usp.br551432358276

Outcome results

None listed

Source: REBEC (via WHO ICTRP)