Drug Drug InteractionPhase 1NCT01350921
Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers
A Phase 1 study testing Ticagrelor and Venlaflaxin in people with Drug Drug Interaction, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Ticagrelor and Venlaflaxin
- Type of treatment
- Pill or oral medicine
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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 evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers
- Conditions
- Drug Drug Interaction
- Being tested
- Ticagrelor, Venlaflaxin
- Keywords
- phase 1, ticagrelor, venlafaxine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
Measured: Multiple assessments during day 8 and 9.
Secondary outcomes (2)
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
Measured: 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
Measured: Multiple assessments from day -1 do day 12 and a single assessment at follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Horrow, PhD, Study director, AstraZeneca WilmingtonMirjana Kujacic, PhD, Study chair, AstraZeneca MölndalKelli Craven, MD, Principal investigator, Quintiles Kansas Overland Park US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350921
- Sponsor's protocol ID
- D5130C00073
- Status last verified
- Mar 2012
- First submitted
- 9 May 2011
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01350921
- Acronym / sponsor ID
- D5130C00073
- Conditions
- Drug Drug Interaction
- Keywords
- phase 1, ticagrelor, venlafaxine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor90 mg oral immediate release tablets, single dose on days 1 and 9 | Drug | – |
| Venlaflaxin37.5 mg oral immediate release tablets, administered twice daily on days 4-8 | Drug | – |
Primary outcome
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):
2 secondary outcomes
Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Horrow, PhD study director
AstraZeneca Wilmington
Mirjana Kujacic, PhD study chair
AstraZeneca Mölndal
Kelli Craven, MD principal investigator
Quintiles Kansas Overland Park US
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ticagrelor and Venlaflaxin in people with Drug Drug Interaction, run by AstraZeneca at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.