Status:
COMPLETED
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Pharmacokinetics
Eligibility:
FEMALE
18-49 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 othe...
Eligibility Criteria
Inclusion
- Healthy pre-menopausal female subjects
- Between the ages of 18 and 49 years
- With an intact uterus and cervix
- (Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Exclusion
- Negative serum pregnancy test at screening and should be using at least one method of contraception
- Body Mass Index (BMI) of approximately 18 to 30 kg/m\^2
- And a total body weight \> 50 kg (110 lbs)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00746499
Start Date
September 1 2008
End Date
November 1 2008
Last Update
October 15 2012
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27613