Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, ~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1, Open-Label Study, Investigating First-Dose and Steady-State Pharmacokinetics of Raltegravir in the Genital Tract of HIV Uninfected Women|
- Drug levels in CVF and blood plasma [ Time Frame: Day 1-9 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
No control group, only one active arm with subjects taking Raltegravir.
400mg raltegravir BID x 7 days
Other Name: Isentress
This study is looking at blood and cervicovaginal fluid (CVF) samples of healthy volunteers taking raltegravir. The purpose of this study is to measure the extent that raltegravir penetrates into other body compartments, such as the genital tract. Subjects will take the study drug for 7 days, a total of 10 visits to the research center will be required. A screening visit will occur on no more than 28 days On Days 1 and 7 the subject will stay in the research center for approximately 12 hours for scheduled blood and CVF sampling. Days 3-6 and 8-9 will involve a short visit to the research center for one pre-dose blood and CVF sample before the morning dose. A follow up visit will occur about 7-10 days after last dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746499
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27613|
|Principal Investigator:||Angela DM Kashuba, PharmD||University of North Carolina|