EP4 receptor antagonism and PGE2 in a human headache model

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 14

Inclusion Criteria

•Healthy trial subjects of either gender, 18–55 years of age.
•Body Mass Index 21–29 kg/m2 [body mass index = body weight (kg) ÷ height (m)]2.
•Fertile women must use reliable contraception; this does not apply to women who have had hysterectomies or to women 2 years post-menopause or longer. Reliable contraception is either an IUD + condom, birth control pills + condom, surgical sterilisation of the woman, or a depot gestagen.
•Non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml at screening).
•No clinically significant out of range values in tests of serum biochemistry, hæmatology or urinalysis at screening (see Appendix 1).
Negative urinary drugs of abuse screen at screening (see Appendix 1).
•Negative HIV and hepatitis B and C results
•Trial subjects must fulfil the inclusion criteria entirely, be willing and able to comply fully with the requirements of the study and be available to take part in the study.
•Trial subjects must be found to be healthy in a physical examination before the study begins.
•Trial subjects must sign the informed consent for participation in the study. Subjects will be informed about the nature, procedures, requirements, and restrictions of the trial. They will also be informed about risks, benefits/ compensation, and confidentiality (data protection), as well as about the voluntary nature of participation and whom to contact regarding questions or problems. Each subject willing to participate in the trial must sign and date an informed consent document, a copy of which will be given to the subject.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Tension headache [32] more than once a month on average in the recent years.
•All other primary forms of headache [32].
•Painful or inflammatory diseases.
•Raynaud’s phenomenon.
•Systemic sclerosis or vasculitis.
•Gastric ulcers or dyspepsia.
•Gastrointestinal disease with possible influence on the uptake of medicine.
•NSAID hypersensitivity.
•Known allergy to the study drug constituents including lactose (incompatibility)
•Intake of prescription or over-the-counter medicine within 14 days before the first study day. Daily intake of medicine of any kind except for an oral contraceptive.
•Intake of any form of medicine later than 4 times the plasma half-life of the relevant substance (on the study day) apart from an oral contraceptive.
•Vitamins, minerals and other nutritional supplements may be taken upon having notified the investigator of them.
•Previous history with any relevant abnormal findings for kidney, liver, mental, neurological, respiratory, cardiovascular or gastrointestinal diseases.
•Abnormal laboratory findings pointing to infectious, endocrinal, or other systemic diseases.
•Trial subjects must not have abnormal ECG deviations within a period of 14 days before the first dose.
•Pregnant or lactating women (negative urine HCG pregnancy test at screening)
•Headache on the study day or within 24 hours before intake of the study medicine or placebo.
•Trial subjects must not have clinically significant deviations in blood pressure or pulse within 14 days before the first dose.
•Persons with systolic blood pressure elevation greater than 20 mmHg or pulse increased more than 20 beats per minute on changing from a supine to standing position.
•Inclusion interview revealing medical history or clinical signs of:
ohypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg);
ohypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
•Cardiovascular disease of any kind, including cerebrovascular disease.
•Anamnestic or clinical signs of mental illness or substance abuse
•Trial subjects not willing to limit alcohol intake to 2 units per day for 7 days before the first dose and to entirely abstain from alcohol consumption 2 days before the study days until the trial period is finished.
•Trial subjects not willing to abstain from caffeine intake 2 days before the study and until the end of the study.
•Incapacity to communicate properly with the investigator (due for example to speech difficulties, insufficient mental development, or reduced cerebral function).
•Participation in a clinical study of a medicine without regulatory approval or marketing authorisation within 1 month before this trial.
•Blood donation >500 ml within last 3 months.
•Trial subjects subject to time changes and/or jet lag due to long distance travel or work in the night hours.