Peripheral Nociceptive Effects of Levcromakalim

Study Overview
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Brief Summary
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Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated: Prevalence and intensity of pain Prevalence and intensity of itching Occurrence and intensity of local redness and swelling Occurrence and intensity of local changes in skin temperature and blood flow

Official Title
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Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim

Conditions
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Pain, Levcromakalim

Intervention / Treatment
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* Drug: Levcromakalim
* Drug: Saline


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 potential must use adequate contraception. Exclusion Criteria: A history of serious somatic disease Migraine or any other type of headache (except episodic tension-type headache less than once a 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: Parallel, randomized placebo controlled and crossover study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levcromakalim<br>To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0. | Drug: Levcromakalim<br>* To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.<br>Drug: Saline<br>* To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.<br>|
| Placebo Comparator: Saline<br>To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0. | Drug: Levcromakalim<br>* To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.<br>Drug: Saline<br>* To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and change of pain from baseline | Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used. The outcome measure is pain and the unit that will be used to measure the pain is NRS. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection | 
| Occurrence and change of Itching from baseline | Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used. The outcome measure is itching and the unit that will be used to measure the itching is NRS. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and change of redness from baseline | Occurrence and change of redness after levcromakalim injektion compared to placebo. The areal of the redness will be measured. The outcome measure is redness and the unit that will be used to measure the redness is areal cm^2. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection. | 
| Occurrence and change of swelling from baseline | Occurrence and change of swelling after levcromakalim injektion compared to placebo. The areal of the swelling will be measured. The outcome measure is swelling and the unit that will be used to measure the swelling is areal cm^2. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection. | 
| Change of blood flow from baseline | Change of blodflow after levcromakalim injektion compared to placebo. The intensity of the blodd flow will be measured by laser speckle The outcome measure is change of blood flow and the laser speckle will be used to measure the blood flow. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection. | 
| Change of skin temperature from baseline | Change of skin temperature after levcromakalim injektion compared to placebo. The temperature will be measured by thermovision camera. The outcome measure is the change of skin temperature and the thermovision camera will be used to measure skin temperature. | Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection. |