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Completed

NCT Number: NCT01350921

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

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

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Key information

Conditions

Drug Drug Interaction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Uppsala, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

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

Venlaflaxin

Drug

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

Primary outcomes

  1. area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)

    Time frame: 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 outcomes

  1. Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2011
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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