Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00808184
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2008-12-11
Brief Title:
Pharmacokinetic Study of CPT-11 Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Pharmacokinetic Study of CPT-11 Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
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:
The objectives of this study are
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan CPT-11 and its metabolite SN-38
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan CPT-11 and its metabolite SN-38
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population
Detailed Description:
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan CPT-11 and its metabolite SN-38
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population
VI Abstract of Research Proposal In no more than 300 words describe concisely the specific aims hypotheses methodology and approach of the application indicating where appropriate the applications importance to science or medicine The abstract must be self-contained so that it can serve as a succinct and accurate description of the application when separated from it Please use lay terms If this not possible the technical and medical terms should be explained in simple language The pharmacokinetic parameters of raltegravir will correlate well with irinotecan CPT-11 and its metabolite SN-38 and better than midazolam
Raltegravir pharmacokinetic parameters can be used to predict the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan Patients who are prescribed the CPT-11 containing regimen FOLFIRI will be selected for the study
Subjects will then undergo the raltegravir and midazolam test one day before the first dose of their chemotherapy Pharmacokinetic sampling will occur for these 2 days The raltegravir and midazolam test will be carried out under fasting conditions minimum 10 hours Between 8 to 9 am one mg of midazolam will be administered intravenously over 30 seconds At the same time raltegravir 400 mg will be administered orally with water Blood samples will be drawn at specified times for pharmacokinetic analysis from a heparinised butterfly needle in the opposite arm
On the next day FOLFIRI will be administered as follows
CPT-11 at 180 mgm2 in 250 mL Normal Saline over 90 min followed by Leucovorin at 400 mgm2 in 250 mL Normal Saline over 2 hours followed by 5-Flourouracil 400 mgm2 IV bolus followed by 5-Flourouracil 2400 mgm2 over 46 hours Premedications may be administered as per routine clinical practice Blood will be taken at specified times for pharmacokinetic analysis The pharmacokinetic parameters of the raltegravir and midazolam will be compared with the pharmacokinetic parameters of CPT-11 and its metabolite SN-38 Correlation analysis will be performed on the parameters to find the raltegravir or midazolam parameters which correlate best with the CPT-11 and SN-38 parameters CPT-11 and raltegravir parameters will be correlated with UGT1A1 and other demographic information
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population
VI Abstract of Research Proposal In no more than 300 words describe concisely the specific aims hypotheses methodology and approach of the application indicating where appropriate the applications importance to science or medicine The abstract must be self-contained so that it can serve as a succinct and accurate description of the application when separated from it Please use lay terms If this not possible the technical and medical terms should be explained in simple language The pharmacokinetic parameters of raltegravir will correlate well with irinotecan CPT-11 and its metabolite SN-38 and better than midazolam
Raltegravir pharmacokinetic parameters can be used to predict the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan Patients who are prescribed the CPT-11 containing regimen FOLFIRI will be selected for the study
Subjects will then undergo the raltegravir and midazolam test one day before the first dose of their chemotherapy Pharmacokinetic sampling will occur for these 2 days The raltegravir and midazolam test will be carried out under fasting conditions minimum 10 hours Between 8 to 9 am one mg of midazolam will be administered intravenously over 30 seconds At the same time raltegravir 400 mg will be administered orally with water Blood samples will be drawn at specified times for pharmacokinetic analysis from a heparinised butterfly needle in the opposite arm
On the next day FOLFIRI will be administered as follows
CPT-11 at 180 mgm2 in 250 mL Normal Saline over 90 min followed by Leucovorin at 400 mgm2 in 250 mL Normal Saline over 2 hours followed by 5-Flourouracil 400 mgm2 IV bolus followed by 5-Flourouracil 2400 mgm2 over 46 hours Premedications may be administered as per routine clinical practice Blood will be taken at specified times for pharmacokinetic analysis The pharmacokinetic parameters of the raltegravir and midazolam will be compared with the pharmacokinetic parameters of CPT-11 and its metabolite SN-38 Correlation analysis will be performed on the parameters to find the raltegravir or midazolam parameters which correlate best with the CPT-11 and SN-38 parameters CPT-11 and raltegravir parameters will be correlated with UGT1A1 and other demographic information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None