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Infection, Human Immunodeficiency VirusPhase 1NCT01195974

A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.

A Phase 1 study testing YASMIN and GSK2248761 in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
YASMIN and GSK2248761
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteUnited States
Study dates
14 Sep 2010to 9 Feb 2011
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin greater than 1.5xUpper limit of normal is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
  • Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Female, between 18 and 40 years of age inclusive, at the time of signing the informed consent.
  • Women of childbearing potential must use the following appropriate contraceptive methods: oral contraceptive YASMIN in combination with complete abstinence from intercourse for at least 14 days prior to the first dose of investigational product (Day 1 of Period 1), throughout the study, and for the subsequent post study monitoring or; YASMIN in combination with a barrier method plus a spermicide (e.g., condom or diaphragm with spermicidal foam/gel/cream/ suppository for at least 14 days prior to the first dose of investigational product [Day 1 of Period 1]) throughout the study, and for the subsequent post study monitoring or; Sterilization (vasectomy) of male partner prior to commencement of female subject's last normal menstrual period prior to administration of study drug, and the male partner is the sole partner for that female subject;
  • The subject's Body Mass Index is 19 to 30 killograms/millimeters squared and body weight greater than or equal to 50 kilograms (110 pounds) and less than 114 kilograms (less than 250 pounds);
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
  • Single QTc, QTcB or QTcF less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block

Who cannot join

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >7 drinks for females.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Show all 19Show fewer
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mililiters within a 56 day period.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception from at least 14 days prior to the first dose of investigational product until completion of the follow-up visit;
  • Pregnant females as determined by positive hCG test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • History of any condition that would contraindicate OC administration (including hypertension, stroke, ischemic heart disease, venous thromboembolism, carcinoma of the breast, etc.);
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Subjects who have asthma or a history of asthma, (e.g., for any FTIH where risk of bronchoconstriction is unknown, or compound specific where risk of bronchoconstriction).
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Drospirenone and Ethinyl Estradiol When Co-administered With GSK2248761 in Healthy Adult Female Subjects

This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods. The length of the Run-in Period will be 28 days or longer, depending on the timing of the subject's menstrual cycle and on whether the subject is taking an OC. Each subject will participate in this run-in period (if needed), followed by two treatment periods. Treatment Periods 1 and 2 must be conducted successively. Subjects will be randomized in a cross-over fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or placebo for another 10 days. Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.

Read the detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Being tested
YASMIN, GSK2248761, Placebo
Keywords
oral contraceptive, drug interaction, pharmacokinetics
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YASMINDrug

    YASMIN for 21 days

  • GSK2248761Drug

    200 mg GSK2248761 taken on Days 1 - 10 or Days 12 - 21

  • PlaceboOther

    Placebo taken on Days 1 - 10 or Days 12 - 21

Study groups in NCT01195974
Study groupRoleWhat they receive
Period 1ExperimentalYASMIN + 200 mg GSK2248761 or Placebo
Receives: Drug: YASMIN; Drug: GSK2248761; Other: Placebo
Period 2ExperimentalYASMIN + 200 mg GSK2248761 or Placebo
Receives: Drug: YASMIN; Drug: GSK2248761; Other: Placebo
Run In PeriodOtherYASMIN
Receives: Drug: YASMIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC of Drospirenone and Ethinyl Estradiol after YASMIN alone and after YASMIN with GSK2248761.

    Measured: 21 days

Secondary outcomes (4)

  1. Safety and tolerability of all treatments as assessed by 12 lead electrocardiograms, vital signs, adverse events, and clinical laboratory tests.

    Measured: two months

  2. The maximum observed plasma concentration, the minimum observed plasma concentration, time of occurrence for maximum drug concentration, time of occurrence for minimum drug concentration and the half life of DRSP and EE

    Measured: 21 days

  3. Predose serum levels of Luteinizing Hormone and Follicle-Stimulating Hormone from Periods 1 and 2

    Measured: 21 days

  4. Predose serum levels of progesterone from Periods 1 and 2

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2010 (estimated)
  2. Study start14 Sep 2010
  3. Primary completion9 Feb 2011
  4. Study completion9 Feb 2011

Why it stopped: In a Phase II study in HIV-infected patients there were a number of seizures, although exact causality could not be assessed phase 1 activity was terminated.

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01195974
Sponsor's protocol ID
113394
Status last verified
Feb 2019
First submitted
3 Sep 2010
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • Piscitelli S, Kim J, Gould E, Lou Y, White S, de Serres M, Johnson M, Zhou XJ, Pietropaolo K, Mayers D. Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor. Br J Clin Pharmacol. 2012 Aug;74(2):336-45. doi: 10.1111/j.1365-2125.2012.04194.x.

    PubMed 22288567

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YASMIN and GSK2248761 in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 20 Feb 2019. 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 was stopped early (reason given: In a Phase II study in HIV-infected patients there were a number of seizures, although exact causality could not be assessed phase 1 activity was terminated.). Results are not available in the source record.

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?

AUC of Drospirenone and Ethinyl Estradiol after YASMIN alone and after YASMIN with GSK2248761. (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01195974, which also lists 1 linked publication.

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 20 Feb 2019.

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