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

Phase 1

Completed

• Conditions: Blood Flow Speed; Coronary Flow Velocity
• Interventions: Drug: AZD6140; Drug: Placebo

• Registration Number: NCT01226602
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD6140	Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
2	Placebo	Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 6 h at visit 3

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden