Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use

NCT02977208 | Completed Phase 4

• 1 other identifier: OCTGab
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and other possible covariates on the kinetic disposition of GAB in patients undergoing GAB chronic treatment. Thus, patients treated with GAB, for at least one week, are being investigated.

Conditions

Epilepsy; Chronic Pain

Keywords

Gabapentin; OCT2; OCTN1; Pharmacogenetics; Pharmacokinetics; Polymorphisms

Outcome Measures

Primary Outcomes (2)

• Gabapentin plasma concentration.

  Blood samples will be collected at 0, 90 and 240 minutes after gabapentin administration. The gabapentin plasma concentration will be assessed using liquid chromatography with UV detection (LC-UV).

  Up to 240 minutes after gabapentin administration.

• OCT2 and OCTN1 genotyping

  The single nucleotide polymorphisms of SLC22A2 gene (c.808G\>T) and SLC22A4 (c.1507C\>T) are being evaluated in all included patients.

  Up to 5 minutes before gabapentin administration

Study Arms (2)

Homozygous for the wild type allele

ACTIVE COMPARATOR

Patients with 18 years old or older with epilepsy, neuropathic pain or any chronic pain undergoing chronic treatment with gabapentin are being recruited. Sparse blood sampling are being collected up to 4 h after administration of the drug for pharmacokinetic study. Urine sampling are being collected during the dosing interval, only in patients hospitalized at the Hospital Estadual de Américo Brasiliense (HEAB). Blood sample are being collected for DNA extraction. DNA are being extracted from the whole blood of all patients for genotyping of the SLC22A2 c.808G\>T and SLC22A4 c.1507C\>T polymorphisms.

Procedure: Sparse blood sampling; Procedure: Urine sampling; Procedure: DNA extraction; Drug: Gabapentin

Homo- or heterozygous for rare alleles

ACTIVE COMPARATOR

Patients with 18 years old or older with epilepsy, neuropathic pain or any chronic pain undergoing chronic treatment with gabapentin are being recruited. Sparse blood sampling are being collected up to 4 h after administration of the drug for pharmacokinetic study. Urine sampling are being collected during the dosing interval, only in patients hospitalized at the Hospital Estadual de Américo Brasiliense (HEAB). Blood sample are being collected for DNA extraction. DNA are being extracted from the whole blood of all patients for genotyping of the SLC22A2 c.808G\>T and SLC22A4 c.1507C\>T polymorphisms.

Procedure: Sparse blood sampling; Procedure: Urine sampling; Procedure: DNA extraction; Drug: Gabapentin

Interventions

Sparse blood sampling PROCEDURE

Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.

Homo- or heterozygous for rare alleles; Homozygous for the wild type allele

Urine sampling PROCEDURE

Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).

Homo- or heterozygous for rare alleles; Homozygous for the wild type allele

DNA extraction PROCEDURE

Blood sample are being collected for DNA extraction. DNA are being extracted from the whole blood of all patients for genotyping of the SLC22A2 c.808G\>T and SLC22A4 c.1507C\>T polymorphisms

Homo- or heterozygous for rare alleles; Homozygous for the wild type allele

Gabapentin DRUG

All patients undergoing chronic treatment with gabapentin are being recruited.

Also known as: GAB

Homo- or heterozygous for rare alleles; Homozygous for the wild type allele

Eligibility Criteria

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

You may qualify if:

• Patients with 18 years old or older, both gender.
• Patients undergoing chronic use of gabapentin (at least one week).

You may not qualify if:

• Pregnant and lactating patients.
• Patients who were in use of OCT2 and OCTN1 inhibitors.
• Patients who disagree to continue the study.

Sponsors & Collaborators

• São Paulo State University: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Araraquara, São Paulo, 14800903, Brazil

Location

MeSH Terms

Conditions

Epilepsy; Chronic Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fabíola D. Eckeli, Prof.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Edgar Ianhez Júnior

  Hospital Estadual de Américo Brasiliense

  PRINCIPAL INVESTIGATOR

• Natália V. de Moraes, Prof.

  Universidade Estadual Paulista Júlio de Mesquita Filho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 30, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)