Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)