PGE2 will induce headache in healthy subjects and BGC20-1531 or placebo will be used to block the developement of headache. In the future BGC20-1531 might be a possible anti-migraine drug.
Conditions
Interventions
Trade Name: BGC20-1531
Product Name: BGC20-1531
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Danish Headache Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: o hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg); o hypotension (systolic blood pressure 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is: • to investigate the blocking effects of two different single doses of the EP4 receptor antagonist, BGC20-1531, on PGE2-induced headache in healthy male and female subjects ;Secondary Objective: The secondary objectives are: • to investigate the blocking effects of two different single doses of BGC20-1531 on PGE2-induced drop in mean flow velocity in the middle cerebral artery (Vmean MCA), dilatation of superficial temporal artery (STA) and the radial artery (RA) in healthy subjects, • to investigate the effects of a single dose of BGC20-1531 on Vmean MCA and diameter of the STA and RA in healthy subjects. • to assess the pharmacokinetic/pharmacodynamic interactions of two different single doses of BGC20-1531. • to confirm the safety of single doses of BGC20-1531 in healthy subjects. ;Primary end point(s): Phase 1 Calculation of the number of trial subjects is based on the measurement of differences in pain intensity between treatments with reduction of pain in VRS at 5% significance limit with 90% power. It is assumed that each trial subject will show 20% variation in VRS. A 70% pain reduction will be considered to be of clinical significance. Phase 2 Calculation of the sample size is based on detection of a difference between treatments in VMCA reduction at 5% significance (two-sided) with 80% power. It is assumed that each patient would show a 10% standard variation in VMCA. A true change in the dependent variables is considered 20%. | — |
Countries
Denmark
Outcome results
None listed