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Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

NCT ID: NCT00746499

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

No control group, only one active arm with subjects taking Raltegravir.

Group Type EXPERIMENTAL

Raltegravir

Intervention Type DRUG

400mg raltegravir BID x 7 days

Interventions

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Raltegravir

400mg raltegravir BID x 7 days

Intervention Type DRUG

Other Intervention Names

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Isentress

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela DM Kashuba, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #08-0984

Identifier Type: -

Identifier Source: org_study_id