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Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01350921
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):

Brief Summary:
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers

Condition or disease Intervention/treatment Phase
Drug Drug Interaction Drug: Ticagrelor Drug: Venlaflaxin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years
Study Start Date : May 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Intervention Details:
  • Drug: Ticagrelor
    90 mg oral immediate release tablets, single dose on days 1 and 9
  • Drug: Venlaflaxin
    37.5 mg oral immediate release tablets, administered twice daily on days 4-8

Primary Outcome Measures :
  1. area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax) [ Time Frame: Multiple assessments during day 8 and 9. ]
    Venlafaxine and O-desmethylvenlafaxine (ODV) on Day 8 (after multiple dose administration of venlafaxine for 4 days) and Day 9 (after concomitant administration of venlafaxine and ticagrelor):

Secondary Outcome Measures :
  1. Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax) [ Time Frame: Multiple assessments during day 1 and 9-11 ]
    Ticagrelor and AR-C124910XX on Day 1 (after single dose administration of ticagrelor) and Day 9 (after concomitant administration of venlafaxine and ticagrelor): area under the plasma concentration-time curve from zero to infinity (AUC), Cmax, tmax and apparent terminal half-life t½λz

  2. Safety and tolerability of ticagrelor and venlafaxine when given concomitantly by assessments of amount of adverse events [ Time Frame: Multiple assessments from day -1 do day 12 and a single assessment at follow up visit. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2

Exclusion Criteria:

  • History of clinically significant disease or disorder as judged by the investigator
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug.
  • History of haemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that may alter or increase bleeding.
  • History of previous or ongoing psychiatric disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01350921

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United States, Kansas
Research Site
Overland Park, Kansas, United States
Research Site
Uppsala, Sweden
Sponsors and Collaborators
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Study Director: Jay Horrow, PhD AstraZeneca Wilmington
Study Chair: Mirjana Kujacic, PhD AstraZeneca Mölndal
Principal Investigator: Kelli Craven, MD Quintiles Kansas Overland Park US
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Responsible Party: AstraZeneca Identifier: NCT01350921    
Other Study ID Numbers: D5130C00073
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012
Keywords provided by AstraZeneca:
phase 1
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs