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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01350921
• Collaborator: (none)
• Enrollment: 22
• Locations: 2
• Duration (Months): 10
• Patients Per Site: 11
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States
2	Research Site	Uppsala		Sweden

Sponsors and Collaborators

• AstraZeneca

Investigators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01350921
• Other Study ID Numbers: D5130C00073
• First Posted: May 10, 2011
• Last Update Posted: Mar 30, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by AstraZeneca: phase 1; ticagrelor; venlafaxine
• Additional relevant MeSH terms: Ticagrelor

Study Results

No Results Posted as of Mar 30, 2012