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Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

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ClinicalTrials.gov Identifier: NCT00746499
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Pharmacokinetics Drug: Raltegravir Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
No control group, only one active arm with subjects taking Raltegravir.
Drug: Raltegravir
400mg raltegravir BID x 7 days
Other Name: Isentress


Outcome Measures

Primary Outcome Measures :
  1. Drug levels in CVF and blood plasma [ Time Frame: Day 1-9 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00746499     History of Changes
Other Study ID Numbers: IRB #08-0984
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action