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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01226602
First received: October 21, 2010
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Blood Flow Speed
Coronary Flow Velocity
 Drug: AZD6140
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: During 6 h at visit 2 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: During 6 h at visit 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: During 6 h at visit 2 ] [ Designated as safety issue: No ]
  • Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6h at visit 2 ] [ Designated as safety issue: No ]
  • Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6 h at visit 3 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
 Drug: AZD6140
P2Y12 receptor antagonist
Other Name: Ticagrelor
Placebo Comparator: 2
Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226602

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jay Horrow, MD AstraZeneca
Principal Investigator: Marianne Hartford, MD CTC, Göteborg
Study Chair: Mirjana Kujacic, MD PhD AstraZeneca, Mölndal Sweden
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01226602     History of Changes
Other Study ID Numbers: D5130C00067, 2010-021820-91
Study First Received: October 21, 2010
Last Updated: February 10, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Ticagrelor
Healthy
Coronary flow velocity
Adenosine

Additional relevant MeSH terms:
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013