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
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedOctober 15, 2012
October 1, 2012
2 months
September 3, 2008
October 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Drug levels in CVF and blood plasma
Day 1-9
Study Arms (1)
1
EXPERIMENTALNo control group, only one active arm with subjects taking Raltegravir.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27613, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela DM Kashuba, PharmD
University of North Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 4, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
October 15, 2012
Record last verified: 2012-10