Bioavailability Heathy VolunteersPhase 1NCT01887626
Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.
A Phase 1 study testing Ticagrelor 90 mg whole tablet, Ticagrelor 90 mg tablet crushed and Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube in people with Bioavailability Heathy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Heathy Volunteers
- What is being tested?
- Ticagrelor 90 mg whole tablet, Ticagrelor 90 mg tablet crushed and Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Sep 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
- Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds [lbs]) and no more than 100 kg (220 lbs).
- Provision of signed and dated, written informed consent prior to any study specific procedures
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
- A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
- History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer
Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.
Read the detailed description
Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
- Conditions
- Bioavailability Heathy Volunteers
- Being tested
- Ticagrelor 90 mg whole tablet, Ticagrelor 90 mg tablet crushed, Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube
- Keywords
- Phase 1, pharmacokinetic, safety, Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90 mg whole tabletDrug
Ticagrelor 90 mg whole tablet administered as a single oral dose
Ticagrelor 90 mg tablet crushedDrug
Ticagrelor 90 mg crushed and suspended in water
Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tubeDrug
Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ticagrelor 90 mg as a whole tablet Receives: Drug: Ticagrelor 90 mg whole tablet |
| B | Experimental | Ticagrelor 90 mg tablet crushed and suspended in water Receives: Drug: Ticagrelor 90 mg tablet crushed |
| C | Experimental | Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach Receives: Drug: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
Measured: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
Measured: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
Measured: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
Measured: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Secondary outcomes (5)
Description of the safety profile in terms of adverse events (AE)
Measured: From first dose through to the follow-up visit.
Description of the safety profile in terms of laboratory variables
Measured: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Description of the safety profile in terms of vital signs
Measured: Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Description of the safety profile in terms of physical examination findings
Measured: Physical examination at screening, pre-dose, Day 3 and follow-up
Description of the safety profile in terms of Electrocardiogram (ECG)
Measured: ECGs at screening, Day 3 and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability Heathy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Hsia, MD, Study director, AstraZeneca, Wilmington, USMirjana Kujacic, MD, Study chair, AstraZeneca Mölndal, SwedenSaeed Kahn, MBBS, Principal investigator, Quintiles London, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887626
- Sponsor's protocol ID
- D5130C00076
- Status last verified
- Sep 2013
- First submitted
- 25 Jun 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT01887626
- Acronym / sponsor ID
- D5130C00076
- Conditions
- Bioavailability Heathy Volunteers
- Keywords
- Phase 1, pharmacokinetic, safety, Ticagrelor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Jun 2013 (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 to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.
Detailed description
Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ticagrelor 90 mg whole tabletTicagrelor 90 mg as a whole tablet |
| B | Experimental | Drug: Ticagrelor 90 mg tablet crushedTicagrelor 90 mg tablet crushed and suspended in water |
| C | Experimental | Drug: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tubeDispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
- Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds [lbs]) and no more than 100 kg (220 lbs).
- Provision of signed and dated, written informed consent prior to any study specific procedures
Key exclusion criteria (4 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
- A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
- History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator
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 |
|---|---|---|
| Ticagrelor 90 mg whole tabletTicagrelor 90 mg whole tablet administered as a single oral dose | Drug | A |
| Ticagrelor 90 mg tablet crushedTicagrelor 90 mg crushed and suspended in water | Drug | B |
| Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tubeDispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach | Drug | C |
Primary outcome
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
5 secondary outcomes
Description of the safety profile in terms of adverse events (AE)
Time frame: From first dose through to the follow-up visit.
Description of the safety profile in terms of laboratory variables
Time frame: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Description of the safety profile in terms of vital signs
Time frame: Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Description of the safety profile in terms of physical examination findings
Time frame: Physical examination at screening, pre-dose, Day 3 and follow-up
Description of the safety profile in terms of Electrocardiogram (ECG)
Time frame: ECGs at screening, Day 3 and follow-up
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 18 Sep 2013.
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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.
Judith Hsia, MD study director
AstraZeneca, Wilmington, US
Mirjana Kujacic, MD study chair
AstraZeneca Mölndal, Sweden
Saeed Kahn, MBBS principal investigator
Quintiles London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ticagrelor 90 mg whole tablet, Ticagrelor 90 mg tablet crushed and Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube in people with Bioavailability Heathy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
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 3 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor (time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose). The study lists 4 primary outcomes in all. 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 18 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.