Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05437783
Status:
UNKNOWN
Last Update Posted:
2022-06-29
First Post:
2022-06-18
Brief Title:
Influence of Ethnicity and ABCB1 Gene Polymorphism on the Pharmacokinetics of Azithromycin in Healthy Bangladeshi Volunteers
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Influence of Ethnicity and ABCB1 Gene Polymorphism on the Pharmacokinetics of Azithromycin in Healthy Bangladeshi Volunteers A Preliminary Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is well recognized that different patients respond in different ways to the same medication These differences are often greater among members of a population than they are within the same person at different times or between monozygotic twins The existence of large population differences with small interpatient variability is consistent with inheritance as a determinant of drug response it is estimated that genetics can account for 20 to 95 percent of variability in drug disposition and effects Azithromycin is frequently used worldwide irrespective of gender or ethnic populations therefore to investigate the impact of gender and ABCB1 gene polymorphism holds clinical significance As a correlation between azithromycin high plasma level and cardiac arrhythmia also exists If we can prove the variation of pharmacokinetics of azithromycin due to ethnic differences and ABCB1 polymorphism dose adjustment can be done
No relevant study regarding this has been done before in Bangladesh Therefore this preliminary study would be of great benefit to formulate the individualized doses regiment design which may improve the efficacy of drug while reducing adverse reaction At the same time Genotyping may prove an essential tool for individualized treatment by optimizing the drug dosage for an individuals genetic variability Further study regarding pharmacogenetics of various drugs may be possible in our country in the future The present study design to investigate the influence of ethnic difference and gene polymorphism on the pharmacokinetics of azithromycin in Bangladeshi Bangalee and Bangladeshi minor ethnic volunteers
No relevant study regarding this has been done before in Bangladesh Therefore this preliminary study would be of great benefit to formulate the individualized doses regiment design which may improve the efficacy of drug while reducing adverse reaction At the same time Genotyping may prove an essential tool for individualized treatment by optimizing the drug dosage for an individuals genetic variability Further study regarding pharmacogenetics of various drugs may be possible in our country in the future The present study design to investigate the influence of ethnic difference and gene polymorphism on the pharmacokinetics of azithromycin in Bangladeshi Bangalee and Bangladeshi minor ethnic volunteers
Detailed Description:
Individual variation in drug response is a major problem in clinical practices and drug development which ranges from therapeutic failure to adverse drug reaction as drug reaction in multidrug therapy Pharmacogenetic is relevant in this aspect and mainly concern with the study of genetic variation which influence individuals responses to drug Again polymorphism variation in the genes which are involved in encoding drug metabolizing enzymes transporters of drug and ion channels can play role in the adverse drug reaction in an individual or can interfere with the therapeutic efficacy For this reason now-a-days concept of drug treatment is changed from right drug for the right person to right dose for the right person at right time The human multidrug resistance gene ATP-binding cassette ABCB1 codes for P-glycoproteinP-gp an important membrane-bound efflux transporter known to confer anticancer drug resistance as well as affect the pharmacokinetics of many drugs and xenobiotics A number of single nucleotide polymorphisms SNPs have been identified throughout the ABCB1 gene that may have effect on P-gp expression levels and functions Some studies shown an association between ABCB1 gene polymorphism on the pharmacokinetics of azithromycin Genetic studies to explain this topic is uncommon On this context this proposed preliminary study is therefore to investigate the impact of ethnic difference and ABCB1 gene polymorphism on the pharmacokinetics of azithromycin among Bangladeshi people This study will be a single dose open level comparative pharmacokinetic study which will be conducted in the department of Pharmacology BSMMU with the collaboration of Department of Anatomy BSMMU and Bandarban Sadar Hospital Bandarban In this study healthy Bangladeshi volunteers will be divided into two arms-Bangladeshi Bengalese and Bangladeshi minor ethnics residing Chittagong Hill Tracts area a total of 30 healthy volunteers of aged 20-25 will be provided 500mg oral azithromycin tablet and blood samples will be collected before drug administration oh and continuing at time points 05 10 20 30 40 60 80 120 240 480 720 h post dosing2ml peripheral blood will be collected from each subject to determine the ABC1B gene polymorphism This proposed study we would attempt to establish a High-Performance liquid Chromatography HPLC method to determine the azithromycin in plasma in order to evaluate the bioavailability of azithromycin Specific Genotypic polymorphism ABCB1 gene would be determine by Polymerase Chain Reaction-Restriction fragmentation Length Polymorphism Analysis RFLP-PCR After estimation of azithromycin and genotyping ABCB1 gene polymorphism statistical analysis will be done to compare those values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None