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

Phase 1

Completed

• Conditions: Drug Drug Interaction

• Registration Number: NCT01350921
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)	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

Name	Time	Method
Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)	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
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden