BioavailabilityPhase 1NCT02400333

Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet

A Phase 1 study testing Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Ticagrelor OD tablet (90 mg single dose) administered without water and Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube in people with Bioavailability and Healthy Subjects, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bioavailability, Healthy Subjects
What is being tested?: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Ticagrelor OD tablet (90 mg single dose) administered without water and Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteGermany
Study dates: Jun 2015to Jul 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. - Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range or Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. - Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. -Able to understand, read and speak the German language.
Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
Any abnormalities in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), urea, creatinine, thyroid-stimulating hormone (TSH), International Normalised Ratio (INR), activated partial thromboplastin time (aPTT), white blood cell (WBC) count, haemoglobin (Hb) or platelet count. Any other abnormal haematology, clinical chemistry, coagulation or urinalysis results, as judged with an unacceptable deviation that is considered to be clinically significant by the investigator.
Any clinically significant abnormal findings in vital signs, as judged by the investigator. at screening and at baseline (Day -1 of Treatment period 1), defined as:
Systolic blood pressure < 90mmHg or ≥ 140 mmHg
Diastolic blood pressure < 50mmHg or ≥ 90 mmHg

Show all 16Show fewer

Pulse < 50 or > 85 beats per minute (bpm)
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
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, hematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the investigator.
History of a clinically significant non-traumatic bleed or clinically significant bleeding risk, as judged by the investigator.
Use of aspirin, ibuprofen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.
Platelet count less than 150 x 109/L.
Criteria applicable to insertion of a nasogastric tube:
History of severe midface trauma and/or recent nasal surgery.
History of coagulation abnormality, oesophageal varices or stricture, recent banding or cautery of oesophageal varices, and/or alkaline ingestion, at the discretion of the investigator.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin

Other trials in Germany

About this study

Official title: An Open-label, Randomised, Four-period, Four-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioavailability of Ticagrelor Orodispersible Tablets, Compared to Ticagrelor Immediate-release Tablets in Healthy Subjects

This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD) tablets when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets

Read the detailed description

Study to evaluate the bioavailability of ticagrelor OD tablets administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Conditions: Bioavailability, Healthy Subjects
Being tested: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Keywords: ticagrelor orodispersible tablet, ticagrelor immediate-release tablet, relative bioavailability, Phase I, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of waterDrug
Also called Treatment A
90 mg single dose
Ticagrelor OD tablet (90 mg single dose) administered without waterDrug
Also called Treatment B
90 mg single dose
Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tubeDrug
Also called Treatment C
90 mg single dose
Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterDrug
Also called Treatment D
90 mg single dose

Study groups in NCT02400333
Study group	Role	What they receive
Treatments A-D-B-C sequence	Experimental	Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4 Receives: Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water; Drug: Ticagrelor OD tablet (90 mg single dose) administered without water; Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube; Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments B-A-C-D sequence	Experimental	Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4 Receives: Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water; Drug: Ticagrelor OD tablet (90 mg single dose) administered without water; Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube; Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments C-B-D-A sequence	Experimental	Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4 Receives: Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water; Drug: Ticagrelor OD tablet (90 mg single dose) administered without water; Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube; Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments D-C-A-B sequence	Experimental	Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4 Receives: Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water; Drug: Ticagrelor OD tablet (90 mg single dose) administered without water; Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube; Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

Secondary outcomes (10)

Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.
Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.
Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.
Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.
Measured: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Percentage of Participants With Adverse Events (AEs).
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Measured: SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.
Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).
The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.
Measured: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Mean Change From Baseline for Vital Signs in Supine Pulse Rate.
Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.
Measured: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Participants With Significant Findings in 12-Lead Electrocardiography (ECG).
A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.
Measured: At screening and at follow-up.
Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.
Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).
Measured: At screening, at admission on Day -1 to each treatment period and at follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jul 2015

First posted27 Mar 2015 (estimated)
Study startJun 2015
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BioavailabilityStudies 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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02400333
Sponsor's protocol ID: D5139C00003
Status last verified: Aug 2016
First submitted: 9 Mar 2015
Last updated: 29 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Four-period, Four-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioavailability of Ticagrelor Orodispersible Tablets, Compared to Ticagrelor Immediate-release Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT02400333
Acronym / sponsor ID: D5139C00003
Conditions: Bioavailability, Healthy Subjects
Keywords: ticagrelor orodispersible tablet, ticagrelor immediate-release tablet, relative bioavailability, Phase I, healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 27 Mar 2015 (estimated)
Results: Posted 3 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatments A-D-B-C sequence	Experimental	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Drug: Ticagrelor OD tablet (90 mg single dose) administered without water, Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterTreatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4
Treatments B-A-C-D sequence	Experimental	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Drug: Ticagrelor OD tablet (90 mg single dose) administered without water, Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterTreatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4
Treatments C-B-D-A sequence	Experimental	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Drug: Ticagrelor OD tablet (90 mg single dose) administered without water, Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterTreatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4
Treatments D-C-A-B sequence	Experimental	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Drug: Ticagrelor OD tablet (90 mg single dose) administered without water, Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterTreatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. - Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range or Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. - Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. -Able to understand, read and speak the German language.
Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
Any abnormalities in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), urea, creatinine, thyroid-stimulating hormone (TSH), International Normalised Ratio (INR), activated partial thromboplastin time (aPTT), white blood cell (WBC) count, haemoglobin (Hb) or platelet count. Any other abnormal haematology, clinical chemistry, coagulation or urinalysis results, as judged with an unacceptable deviation that is considered to be clinically significant by the investigator.
Any clinically significant abnormal findings in vital signs, as judged by the investigator. at screening and at baseline (Day -1 of Treatment period 1), defined as:
Current smokers or those who have smoked or used nicotine products within the previous 3 months.

Key exclusion criteria (0 listed)

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 OD tablet (90 mg single dose) administered with 200 ml of waterAlso: Treatment A90 mg single dose	Drug	Treatments A-D-B-C sequence, Treatments B-A-C-D sequence, Treatments C-B-D-A sequence, Treatments D-C-A-B sequence
Ticagrelor OD tablet (90 mg single dose) administered without waterAlso: Treatment B90 mg single dose	Drug	Treatments A-D-B-C sequence, Treatments B-A-C-D sequence, Treatments C-B-D-A sequence, Treatments D-C-A-B sequence
Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tubeAlso: Treatment C90 mg single dose	Drug	Treatments A-D-B-C sequence, Treatments B-A-C-D sequence, Treatments C-B-D-A sequence, Treatments D-C-A-B sequence
Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of waterAlso: Treatment D90 mg single dose	Drug	Treatments A-D-B-C sequence, Treatments B-A-C-D sequence, Treatments C-B-D-A sequence, Treatments D-C-A-B sequence

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).

10 secondary outcomes

Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.
Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Percentage of Participants With Adverse Events (AEs).
Time frame: SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.
Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).
Time frame: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Mean Change From Baseline for Vital Signs in Supine Pulse Rate.
Time frame: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Participants With Significant Findings in 12-Lead Electrocardiography (ECG).
Time frame: At screening and at follow-up.
Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.
Time frame: At screening, at admission on Day -1 to each treatment period and at follow-up.

Results and safety

Results posted to the registry on 3 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADBC Sequence	9	8
BACD Sequence	9	8
CBDA Sequence	9	7
DCAB Sequence	9	7

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.

Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 30	Treatment B n = 31	Treatment C n = 33	Treatment D n = 33
Ticagrelor	428 (25.0)	499 (34.0)	479 (32.1)	520 (29.0)
AR-C124910XX	118 (26.5)	126 (24.7)	126 (30.4)	129 (31.8)

Treatment A vs Treatment D: Geometric mean ratio: 84.85 (90% CI 76.77 to 93.78)
Treatment B vs Treatment D: Geometric mean ratio: 96.61 (95% CI 88.22 to 105.79)
Treatment C vs Treatment D: Geometric mean ratio: 92.16 (95% CI 85.59 to 99.25)

Population analysed: The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.

Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.. Geometric mean (Geometric Coefficient of Variation). Unit: h·ng/mL

Measure	Treatment A n = 30	Treatment B n = 31	Treatment C n = 33	Treatment D n = 33
Ticagrelor	3023 (28.6)	3172 (42.6)	3174 (40.9)	3358 (40.0)
AR-C124910XX	1087 (19.7)	1104 (20.7)	1101 (24.4)	1140 (23.0)

Treatment A vs Treatment D: Geometric mean ratio: 95.04 (95% CI 90.33 to 99.99)
Treatment B vs Treatment D: Geometric mean ratio: 95.41 (95% CI 89.94 to 101.21)
Treatment C vs Treatment D: Geometric mean ratio: 94.66 (95% CI 90.53 to 98.98)

Population analysed: The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.

Primary outcome: Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).

Time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.. Geometric mean (Geometric Coefficient of Variation). Unit: h·ng/mL

Measure	Treatment A n = 30	Treatment B n = 31	Treatment C n = 33	Treatment D n = 33
Ticagrelor	3068 (29.2)	3228 (44.2)	3226 (42.9)	3423 (41.8)
AR-C124910XX	1138 (19.1)	1155 (20.7)	1154 (23.6)	1197 (22.5)

Treatment A vs Treatment D: Geometric mean ratio: 94.96 (95% CI 90.27 to 99.89)
Treatment B vs Treatment D: Geometric mean ratio: 95.24 (95% CI 89.81 to 100.99)
Treatment C vs Treatment D: Geometric mean ratio: 94.40 (95% CI 90.26 to 98.73)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were recorded from the signing of the informed consent and adverse events were recorded from randomization until the final follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 31 (0%)	3 of 31 (9.7%)	Not reported
Treatment B	0 of 32 (0%)	5 of 32 (15.6%)	Not reported
Treatment C	0 of 34 (0%)	3 of 34 (8.8%)	Not reported
Treatment D	0 of 33 (0%)	2 of 33 (6.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Rainard Fuhr, Dr. med. principal investigator

PAREXEL International GmbH, Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 0 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 29 Sep 2016. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX. (time frame: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02400333.

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 29 Sep 2016.