Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
 Drug: Raltegravir
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Drug levels in CVF and blood plasma [ Time Frame: Day 1-9 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
No control group, only one active arm with subjects taking Raltegravir.
 Drug: Raltegravir
400mg raltegravir BID x 7 days
Other Name: Isentress

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746499

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27613
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Angela DM Kashuba, PharmD University of North Carolina
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00746499     History of Changes
Other Study ID Numbers: IRB #08-0984
Study First Received: September 3, 2008
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013