Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers
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
1 other identifier
interventional
22
2 countries
2
Brief Summary
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 30, 2012
March 1, 2012
10 months
May 9, 2011
March 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)
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.
Interventions
90 mg oral immediate release tablets, single dose on days 1 and 9
37.5 mg oral immediate release tablets, administered twice daily on days 4-8
Eligibility Criteria
You may qualify if:
- a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Overland Park, Kansas, United States
Research Site
Uppsala, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jay Horrow, PhD
AstraZeneca Wilmington
- STUDY CHAIR
Mirjana Kujacic, PhD
AstraZeneca Mölndal
- PRINCIPAL INVESTIGATOR
Kelli Craven, MD
Quintiles Kansas Overland Park US
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 10, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 30, 2012
Record last verified: 2012-03