| Eligibility |
Inclusion Criteria:
1. Subject is a white male = 18 and = 45 years of age at the time of screening.
2. Subject is a nonsmoker for at least 6 months prior to the study start.
3. Subject has a body mass index = 18 and = 30 kg/m2.
4. Subject has a clear increase in histamine-induced dermal blood flow.
5. Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of
at least 100% as determined during the screening visit.
6. Subject is judged to be in good health on the basis of medical history, physical
examination and vital signs.
7. Subject understands the procedures and agrees to comply with them for the entire
length of the study by giving written informed consent.
Exclusion Criteria:
1. Subject has excessive hair growth on the volar surface of the forearm.
2. Subject has a past or present history of diffuse dermatological conditions including
eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis.
3. Subject has any abnormality on the skin of the forearm, possibly interfering with the
study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts.
4. Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed
which would cause a sunburn reaction) throughout the study and cannot cover the
forearms 24 hours before and after each study visit.
5. Subject currently uses lotions, oils, depilatory preparations, makeup or other topical
treatments on the arms and on a regular basis which cannot be discontinued for the
duration of the study; subject has used any topical treatments within 7 days of the
start of the study.
6. Subject has a past or present history of (symptomatic) asthma.
7. Subject has a history of severe allergic reactions to food or drugs or adverse
experiences of a serious nature related to the administration of either a marketed or
investigational drug, including histamine, cinnamaldehyde, capsaicin, ubrogepant or
sumatriptan.
8. Subject currently uses any prescription or nonprescription drugs on a regular basis
which cannot be discontinued for the duration of the study; subject has used any
prescription or nonprescription medication within 14 days or 5 half-lives of the start
of the study.
9. Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than
approximately 4 cups of tea, coffee or cola per day) at the time of the study.
Subjects who have reduced their consumption to = 4 cups per day at least 1 week prior
to enrollment may participate. Subjects who cannot refrain from caffeinated beverages
24 hours before the study visit.
10. Subject is unable to refrain from drinking alcohol 24 hours prior to histamine
application, is currently a regular user (including "recreational use") of any illicit
drugs, or has a history of drug (including alcohol) abuse. A drug screen will include
amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines,
barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates.
11. Subject cannot refrain from being around secondhand smoke 24 hours prior to histamine
application or uses nicotine-containing products. Ex-smokers should have ceased
smoking at least 6 months prior to screening.
12. Subject has any of the following vital sign measurements at screening: heart rate = 40
or = 100 beats/min, diastolic blood pressure = 50 or = 89 mmHg and/or systolic Blood
Pressure = 90 or = 139 mmHg.
13. Subject has been involved in testing an investigational drug in another clinical study
within the last 4 weeks or 5 half-lives.
14. Subject has evidence of a clinically significant active infection, fever of 38°C or
above at the time of the study visits.
15. Subject has a history or current cardiovascular (e.g. myocardial infarction, ischemic
heart disease, coronary vasospasm, peripheral vascular disease, mild or severe
hypertension or mild uncontrolled hypertension and patients who show symptoms of
ischemic heart disease,), respiratory, hepatic (e.g. severe liver insufficiency),
renal (e.g. severe renal impairment), gastrointestinal or neurological (e.g.
cerebrovascular accident or transient ischemic attacks) disorders capable of
significantly altering the absorption, metabolism or elimination of drugs.
16. Subject is in a situation or has a condition, which, in the opinion of the
investigator, may interfere with safe and optimal participation in the study.
17. Subject has a history of any illness or disorder, which, in the opinion of the
investigator, might confound the results of the study.
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