Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01350921
First received: May 9, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Drug Drug Interaction
Drug: Ticagrelor
Drug: Venlaflaxin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax) [ Time Frame: Multiple assessments during day 1 and 9-11 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Multiple assessments from day -1 do day 12 and a single assessment at follow up visit. ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ticagrelor
    90 mg oral immediate release tablets, single dose on days 1 and 9
    Drug: Venlaflaxin
    37.5 mg oral immediate release tablets, administered twice daily on days 4-8
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350921

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sweden
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01350921     History of Changes
Other Study ID Numbers: D5130C00073
Study First Received: May 9, 2011
Last Updated: March 29, 2012
Health Authority: Sweden: Medical Products Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
phase 1
ticagrelor
venlafaxine

Additional relevant MeSH terms:
Ticagrelor
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014