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

Phase 1CompletedNCT01350921

AstraZeneca22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Drug Drug Interaction

Interventions

TicagrelorDRUG

90 mg oral immediate release tablets, single dose on days 1 and 9

VenlaflaxinDRUG

37.5 mg oral immediate release tablets, administered twice daily on days 4-8

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Overland Park, Kansas, United States

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

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):

Time frame: Multiple assessments during day 8 and 9.

Secondary Outcomes

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

Time frame: 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

Time frame: Multiple assessments from day -1 do day 12 and a single assessment at follow up visit.

Data from ClinicalTrials.gov

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