Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.

Study Overview
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Brief Summary
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The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.

Official Title
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A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects

Conditions
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Blood Flow Speed, Coronary Flow Velocity

Intervention / Treatment
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* Drug: AZD6140
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge Have a body mass index between 18 and 30 kg/m2 Exclusion Criteria: History of clinically significant disease or disorder. Abnormal vital signs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder | Drug: AZD6140<br>* P2Y12 receptor antagonist<br>* Other names: Ticagrelor;|
| Placebo Comparator: 2<br>Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. |  | During 6 h at visit 2 | 
| Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. |  | During 6 h at visit 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline. |  | During 6 h at visit 2 | 
| Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. |  | During 6h at visit 2 | 
| Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. |  | During 6 h at visit 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Healthy, Coronary flow velocity, Adenosine