Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
Recruitment status was Active, not recruiting
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 TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent HMG-CoA reductase inhibitor, is unlikely to interact with TPV/RTV 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 tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetic Evaluation of Single-dose Rosuvastatin 10 mg When Co-administered With Steady-state Tipranavir 500 mg/Ritonavir 200 mg TPV/r) B.I.D. in Healthy Adult Volunteers|
- To compare single dose rosuvastatin AUC0-24h and Cmax with single dose rosuvastatin AUC0-24h and Cmax when co-administered with TPV/r 500 mg/200 mg twice daily at steady state
- To compare single dose rosuvastatin Cp 24h/C last with single dose rosuvastatin Cp 24h/C last when co-administered with TPV/r 500 mg/200 mg twice daily at steady state
- To compare the steady state pharmacokinetics (AUC0-12h, Cmax, Cp 12h/C last) of TPV and RTV (TPV 500 mg/RTV 200 mg B.I.D) with steady state pharmacokinetics of TPV and RTV when co-administered with single dose rosuvastatin (10 mg)
- To evaluate the short term safety and tolerance of TPV/r (500 mg/200 mg B.I.D) combined with single dose rosuvastatin (10 mg)
|Study Start Date:||February 2007|
This is a prospective, open-label pharmacokinetic study in healthy HIV seronegative adults. This study will examine the pharmacokinetic interactions between steady-state TPV/r 500 mg/200 mg B.I.D. 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 mg/RTV 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 TPV/r.
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Paul Pham, PharmD||Johns Hopkins University|