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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Raltegravir

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27613
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Isentress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drug levels in CVF and blood plasma	Day 1-9

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: September 3, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (ESTIMATE): September 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium
• Other Study ID Numbers: IRB #08-0984