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

Drug Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350921
• Other study ID #: D5130C00073
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2011
• Last updated: March 29, 2012
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

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

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the plasma concentration-time curve during a dosing interval (AUCt) 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.	No
Secondary	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 t½?z	Multiple assessments during day 1 and 9-11	No
Secondary	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.	Yes