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

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

Official Title
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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

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Venlaflaxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax) | 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): | Multiple assessments during day 8 and 9. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax) | 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 | Multiple assessments during day 1 and 9-11 | 
| Safety and tolerability of ticagrelor and venlafaxine when given concomitantly by assessments of amount of adverse events |  | Multiple assessments from day -1 do day 12 and a single assessment at follow up visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase 1, ticagrelor, venlafaxine