Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet
Condition: Bioavailability; Healthy Subjects
Intervention: 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
Intervention description: 90 mg single dose; 90 mg single dose; 90 mg single dose; 90 mg single dose
Intervention MeSH terms: Ticagrelor
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ticagrelor orodispersible tablet; ticagrelor immediate-release tablet; relative bioavailability; Phase I; healthy subjects

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.

      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
    

Eligibility criteria:

        Inclusion Criteria:

        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

               -  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.