A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
Status: | Terminated |
---|---|
Conditions: | Infectious Disease, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 2/22/2019 |
Start Date: | September 14, 2010 |
End Date: | February 9, 2011 |
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.
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.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship
updating systems to reflect the change in sponsorship
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
- 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
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