A Randomised, Double-Blind, Placebo-Controlled, Two-Sequence, Two-Period, Crossover Study to Evaluate the Effect of SMP-028 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

SMP-028 is a new medication being developed as a potential treatment for asthma
by Dainippon Sumitomo Pharma. It is not registered as a drug. Asthma is a
respiratory disorder; where the airways are temporarily restricted due to
excessive contraction of the muscles in the walls of the air passages and
swelling of the cells of the air passages. Asthma can be triggered by allergic
reactions, infections, physical exertions and stress.

Preliminary evidence has indicated that SMP-028 may be a potential new broad
spectrum, anti-inflammatory medication.

The purpose of this study is:
• To examine how the combined oral contraceptive pill, which consists of 30
micrograms ethinyl-estradiol and 150 micrograms levonorgestrel (for instance
Microgynon 30®), will be absorbed, metabolized and excreted by the body in
combination with the new drug SMP-028.
• To examine how the new drug SMP-028 will be absorbed, metabolized and
excreted by the body in combination with the combined oral contraceptive pill.
• To examine the safety and tolerability of the new drug SMP-028 in combination
with the combined oral contraceptive pill.
• To evaluate the effect of SMP-028 on the effect that the combined oral
contraceptive pill has on the body hormones (pharmacodynamics).

This study is a double-blind, randomized, placebo-controlled crossover study.

The study will start with a screening. A physical examination and different
standard test (ECG, blood pressure) will be performed during the screening
appointment. Also a cervical smear and an vaginal ultrasound will be performed.
Blood and urine samples will be taken for laboratorium tests and an alchol
breath test and drug screen will be performed. Before the first admission to
the clinic the menstruation cyclus will be synchronized.

During the confinement the medication will be administered to the subjects on
different occasions. Blood samples will also be taken at several occasions. The
subjects will be asked to take medication at home and to complete the time of
intake in the subject diary card. Adverse events will be registered.

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

SMP-028 is not a registered drug. This drug has been given to volunteers before
and was well tolerated. A total of 108 healthy volunteers (84 male and 24
female) have taken part in 3 clinical studies for SMP-028 to date.

Overall, the most commonly reported side effects which may be related to study
drug from these 3 clinical studies were headache (reported in 7 healthy
volunteers), abdominal pain (reported in 3 healthy volunteers), dizziness
(reported in 5 healthy volunteers) and diarrhoea (reported in 3 healthy
volunteers). There may be other unwanted effects that we do not yet know about.

The combined oral contraceptive pill is a registered medicine and is generally
tolerated well but side effects have been described like blood clotting
problems, potentially leading to heart attack or stroke, high blood pressure
and gastro-intestinal complaints.