The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Detailed Description
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22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days. The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration. Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration

Official Title
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The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Conditions
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Migraine, Headache, Pain

Intervention / Treatment
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* Drug: glibenclamide
* Drug: PACAP38


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers of both sexes. 18-60 years. 50-100 kg. Women of childbearing age must use adequate contraception Exclusion Criteria: A history of serious somatic or psychiatric disease Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month) Daily intake of any medication except contraceptives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PACAP38 and glibenclamide<br>Participants will receive glibenclamide after PACAP38 infusion | Drug: glibenclamide<br>* Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .<br>Drug: PACAP38<br>* PACAP38 infusion<br>* Other names: Pituitary adenylate cyclase activating polypeptide-38;|
| Active Comparator: PACAP38 and placebo<br>Participants will receive placebo after PACAP38 infusion | Drug: glibenclamide<br>* Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .<br>Drug: PACAP38<br>* PACAP38 infusion<br>* Other names: Pituitary adenylate cyclase activating polypeptide-38;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache | Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache). | Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA). | Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm) | Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents