Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00764465
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2008-10-01
Brief Title:
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Sponsor:
Garden State Infectious Disease Associates PA
Organization:
Garden State Infectious Disease Associates PA
Study Overview
Official Title:
Steady State Pharmacokinetics PK of Fosamprenavir FPV Alone or in Combination With Low Dose Ritonavir r 1400mg BID 1400mg100mg QD or 700100mg BID and the Chemokine Receptor 5 CCR5 Entry Inhibitor Maraviroc MVC 300mg BID in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-01
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:
To date no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the entry inhibitor maraviroc COL112237 is a randomized open-label 6-arm 3-period drug interaction study to assess steady-state plasma amprenavir APV and maraviroc MVC pharmacokinetics in 48 healthy HIV-negative adults after administration of a 7-day regimen of MVC 300mg BID alone and after 14-day regimens of unboosted fosamprenavir FPV 1400mg twice daily BID FPV 700mgRTV 100mg BID or FPV 1400mgritonavir RTV 100mg once daily QD with and without concurrent MVC 300mg BID Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period Subjects will undergo a physical examination complete blood count CBC with differential HIV test hepatitis BC test liver function test renal function analysis and lipid panel at screening and all of these tests except those for HIV and hepatitis BC will be repeated at follow-up post-study Adverse events and adherence by pill count and medication diary will be assessed by the investigatorstudy personnel at the end of each dosing period
Detailed Description:
This randomized open-label six-arm three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the US The study will have a screening visit 3 treatment visits for PK sampling and a follow-up visit The screening visit will be conducted within 30 days prior to receiving the first dose Subjects will then be randomized into 1 of 6 treatment groups as shown below
Cohort Size Period 1 Days 1 to 7 Period 2 Days 1-14 Period 3 Days 1-14
A 8 MVC 300mg BID FPV 1400mg BID FPV 1400mg BID MVC 300mg BID
B 8 MVC 300mg BID FPV 1400mg BID MVC 300mg BID FPV 1400mg BID
C 8 MVC 300mg BID FPV 700mg BID RTV 100mg BID FPV 700mg BID RTV 100mg BID MVC 300mg BID
D 8 MVC 300mg BID FPV 700mg BID RTV 100mg BID MVC 300mg BID FPV 700mg BID RTV 100mg BID
E 8 MVC 300mg BID FPV 1400mg QD RTV 100mg QD FPV 1400mg QD RTV 100mg QD MVC 300mg BID
F 8 MVC 300mg BID FPV 1400mg QD RTV 100mg QD MVC 300mg BID FPV 1400mg QD RTV 100mg QD
Study subjects will enter the clinic in the morning prior to dosing and remain at the center for 12 hours following each dose Fourteen to 21 days following completion of the third dosing period study subjects will return to the clinic for follow-up assessment The total duration of the study will be approximately 86 days from screening through follow up Blood samples for drug concentration measurement of amprenavir APV and maravirocMVC concentrations will be collected over 12 hours at the end of each dosing period at 0 baseline 05 1 15 2 3 4 6 8 and 12 hours post-dose Subjects will undergo a physical examination CBC with differential HIV test hepatitis BC test liver function test renal function analysis and lipid panel at screening and all of these tests except those for HIV and hepatitis BC will be repeated at follow-up post-study Adverse events and adherence by pill count and medication diary will be assessed by the investigatorstudy personnel at the end of each dosing period Evaluable patients will be required to have adhered to at least 95 of their study drug doses Plasma APV and MVC concentrations will be analyzed using a validated high-performance liquid chromatography method with tandem mass spectrometric detection HPLCMSMS Plasma APV and MVC pharmacokinetic parameters measured will include maximum concentration Cmax time to maximum concentration Tmax minimum concentration Cmin and area under the concentration-time curve AUC All these parameters except Tmax will be log-transformed before statistical analysis Analysis of variance considering treatment as a fixed effect and subject as a random effect will be performed using Statistical Analysis Software SAS and assuming a treatment ratio for steady-state APV PK parameters as 10 the 90 confidence intervals will be within the range 081-124
Cohort Size Period 1 Days 1 to 7 Period 2 Days 1-14 Period 3 Days 1-14
A 8 MVC 300mg BID FPV 1400mg BID FPV 1400mg BID MVC 300mg BID
B 8 MVC 300mg BID FPV 1400mg BID MVC 300mg BID FPV 1400mg BID
C 8 MVC 300mg BID FPV 700mg BID RTV 100mg BID FPV 700mg BID RTV 100mg BID MVC 300mg BID
D 8 MVC 300mg BID FPV 700mg BID RTV 100mg BID MVC 300mg BID FPV 700mg BID RTV 100mg BID
E 8 MVC 300mg BID FPV 1400mg QD RTV 100mg QD FPV 1400mg QD RTV 100mg QD MVC 300mg BID
F 8 MVC 300mg BID FPV 1400mg QD RTV 100mg QD MVC 300mg BID FPV 1400mg QD RTV 100mg QD
Study subjects will enter the clinic in the morning prior to dosing and remain at the center for 12 hours following each dose Fourteen to 21 days following completion of the third dosing period study subjects will return to the clinic for follow-up assessment The total duration of the study will be approximately 86 days from screening through follow up Blood samples for drug concentration measurement of amprenavir APV and maravirocMVC concentrations will be collected over 12 hours at the end of each dosing period at 0 baseline 05 1 15 2 3 4 6 8 and 12 hours post-dose Subjects will undergo a physical examination CBC with differential HIV test hepatitis BC test liver function test renal function analysis and lipid panel at screening and all of these tests except those for HIV and hepatitis BC will be repeated at follow-up post-study Adverse events and adherence by pill count and medication diary will be assessed by the investigatorstudy personnel at the end of each dosing period Evaluable patients will be required to have adhered to at least 95 of their study drug doses Plasma APV and MVC concentrations will be analyzed using a validated high-performance liquid chromatography method with tandem mass spectrometric detection HPLCMSMS Plasma APV and MVC pharmacokinetic parameters measured will include maximum concentration Cmax time to maximum concentration Tmax minimum concentration Cmin and area under the concentration-time curve AUC All these parameters except Tmax will be log-transformed before statistical analysis Analysis of variance considering treatment as a fixed effect and subject as a random effect will be performed using Statistical Analysis Software SAS and assuming a treatment ratio for steady-state APV PK parameters as 10 the 90 confidence intervals will be within the range 081-124
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