PharmacokineticsPhase 1NCT00746499
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
A Phase 1 study testing Raltegravir in people with Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27613
About this study
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
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.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- Raltegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
400mg raltegravir BID x 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | No control group, only one active arm with subjects taking Raltegravir. Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug levels in CVF and blood plasma
Measured: Day 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela DM Kashuba, PharmD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746499
- Sponsor's protocol ID
- IRB #08-0984
- Status last verified
- Oct 2012
- First submitted
- 3 Sep 2008
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00746499
- Acronym / sponsor ID
- IRB #08-0984
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RaltegravirNo control group, only one active arm with subjects taking Raltegravir. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirAlso: Isentress400mg raltegravir BID x 7 days | Drug | 1 |
Primary outcome
Drug levels in CVF and blood plasma
Time frame: Day 1-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela DM Kashuba, PharmD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raltegravir in people with Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug levels in CVF and blood plasma (time frame: Day 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.