Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344123
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2006-06-22
Brief Title:
Pharmacokinetic PK Study of Single-dose Rosuvastatin and TipranavirRitonavir in Healthy Subjects
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Pharmacokinetic Evaluation of Single-dose Rosuvastatin 10 mg When Co-administered With Steady-state Tipranavir 500 mgRitonavir 200 mg TPVr BID in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2016-02
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:
Tipranavir TPV plus ritonavir RTV is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients Since significant cholesterol and triglyceride elevations are commonly reported during TPVRTV treatment effective treatment strategies are critical to prevent long-term cardiovascular events Rosuvastatin a potent 3-hydroxy-3-methylglutaryl-coenzyme HMG-CoA reductase inhibitor is unlikely to interact with TPVRTV since it is not extensively metabolized however a formal drug interaction study is needed before this combination can be recommended This study will examine the pharmacokinetic interactions between tipranavirritonavir TPVRTV TPVr 500 mg200 mg twice daily BID and single dose rosuvastatin when the two are co-administered to healthy adult volunteers The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin 10 mg no significant clinical interaction will occur
Detailed Description:
This is a prospective open-label pharmacokinetic study in healthy HIV seronegative adults This study will examine the pharmacokinetic interactions between steady-state TPVr 500 mg200 mg BID and single dose rosuvastatin 10 mg when the drugs are co-administered
Rosuvastatin 24 hour pharmacokinetic sampling will be performed on days 1-2 and 12-13 Rosuvastatin 48 hr samples will be collected on days 3 and day 14
Tipranavir and ritonavir 12 hour pharmacokinetic sampling will be on day 11 and 12
Safety assessments physical examination vital sign measurements and clinical laboratory tests will be performed at screening during the study and prior to discharge Subjects will be continuously monitored for adverse events throughout the duration of the study
On Day 1 subjects will receive a single 10 mg dose of rosuvastatin Beginning on Day 3 subjects will receive a combination of TPV 500 mgRTV 200 mg twice daily for 11 days Days 3-13
On Day 12 subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPVr
Rosuvastatin 24 hour pharmacokinetic sampling will be performed on days 1-2 and 12-13 Rosuvastatin 48 hr samples will be collected on days 3 and day 14
Tipranavir and ritonavir 12 hour pharmacokinetic sampling will be on day 11 and 12
Safety assessments physical examination vital sign measurements and clinical laboratory tests will be performed at screening during the study and prior to discharge Subjects will be continuously monitored for adverse events throughout the duration of the study
On Day 1 subjects will receive a single 10 mg dose of rosuvastatin Beginning on Day 3 subjects will receive a combination of TPV 500 mgRTV 200 mg twice daily for 11 days Days 3-13
On Day 12 subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPVr
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