One-sequence, two-period, open-label study to evaluate the effects of FTY720 on the pharmacokinetics of an oral contraceptive (levonorgestrel/ethinyl estradiol) in healthy female volunteers.

FTY720 is a new medication developed for the treatment of multiple sclerosis.
Multiple sclerosis, mostly abbreviated as MS, is a disease of the central
nervous system. Multiple sclerosis is caused by the immune system of the body.
In the beginning of the disease process the covering of the nerve bundles are
degenerated in an irregular pattern. This cover, called myelin sheath, is the
insulation around the nerves. Without this insulation the transmission of
signals in the nerve is disrupted causing neurological disturbances in the
patients like paralysis. MS is diagnosed often in adolescents and women are
more often diagnosed than men. The cause of the disease is unknown but current
theories are pointing on a combination of hereditary and environmental factors.

FTY720 acts on acertain type of white blood cells which are responsible for
immunity. Therefore these cells will disappear at the place of the
inflammation. This will decrease the degeneration process of the myelin sheath
and the patient will experience less paralysis symptoms.

The purpose of this investigation is:
• To examine how the new drug FTY720 (study medication) will be absorbed,
metabolized and excreted by the body in combination with the contraception pill
which consists of ethinyl-estradiol and levonorgestrel.
• To examine how the contraception pill, which consists of ethinyl-estradiol
and levonorgestrel, will be absorbed, metabolized and excreted by the body in
combination with the new drug FTY720 (study medication).
• To examine the safety and tolerability of the new drug FTY720 (study
medication) in combination with the contraception pill which consists of
ethinyl-estradiol and levonorgestrel.

One-sequence, two-period, open-label study to evaluate the effects of FTY720 on
the pharmacokinetics of an oral contraceptive (levonorgestrel/ethinyl
estradiol) in healthy female volunteers

The study (including screening and final visit) is taking place in the Xendo
clinical research centre in Groningen.

The study will start with a screening. A physical examination and different
standard test (ECG, blood pressure) will be performed during the screening
appointment. Blood and urine samples will be taken for laboratorium tests and
an alchol breath test and drug screen will be performed.

During the confinement the medication will be administered to the subjects on
different occasions. Blood samples will also be taken at several occasions.
Adverse events will be registered. On almost daily basis ECGs and vitals will
be judged.

At the end of the study a follow-up visit will take place.

FTY720 is not a registered drug. This drug has been given to volunteer before
and was well tolerated. Side effects were mentioned which are probably due to
the medication. These were short of breath, low pulse, low blood pressure, a
decreased electrical conduction of the heart, an increase of liver enzyme
values in the blood and diarrhea.