Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00746499
First received: September 3, 2008
Last updated: October 12, 2012
Last verified: October 2012

September 3, 2008
October 12, 2012
September 2008
November 2008   (final data collection date for primary outcome measure)
Drug levels in CVF and blood plasma [ Time Frame: Day 1-9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746499 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
A Phase 1, Open-Label Study, Investigating First-Dose and Steady-State Pharmacokinetics of Raltegravir in the Genital Tract of HIV Uninfected 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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pharmacokinetics
Drug: Raltegravir
400mg raltegravir BID x 7 days
Other Name: Isentress
Experimental: 1
No control group, only one active arm with subjects taking Raltegravir.
Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
November 2008
November 2008   (final data collection date for primary outcome measure)

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)
Female
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746499
IRB #08-0984
No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Angela DM Kashuba, PharmD University of North Carolina
University of North Carolina, Chapel Hill
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP