Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT00746499

Run by

University of North Carolina, Chapel Hill

People needed

7

Starts

2008-09-01

Expected to finish

2008-11-01

Last updated by the study team

2012-10-15

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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