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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01350921

Enrollment

Registered

2011-05-10

Start date

2011-05-31

Completion date

2012-03-31

Last updated

2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interaction

Keywords

phase 1, ticagrelor, venlafaxine

Brief summary

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

Interventions

DRUGTicagrelor

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

DRUGVenlaflaxin

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

Study design

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.	—

Countries

Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026