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

NCT ID: NCT02400333

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-07-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatments A-D-B-C sequence

Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

Intervention Type: DRUG

90 mg single dose

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

Intervention Type: DRUG

90 mg single dose

Treatments B-A-C-D sequence

Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

Intervention Type: DRUG

90 mg single dose

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

Intervention Type: DRUG

90 mg single dose

Treatments C-B-D-A sequence

Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

Intervention Type: DRUG

90 mg single dose

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

Intervention Type: DRUG

90 mg single dose

Treatments D-C-A-B sequence

Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

90 mg single dose

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

Intervention Type: DRUG

90 mg single dose

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

Intervention Type: DRUG

90 mg single dose

Interventions

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

90 mg single dose

Intervention Type: DRUG

Ticagrelor OD tablet (90 mg single dose) administered without water

90 mg single dose

Intervention Type: DRUG

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

90 mg single dose

Intervention Type: DRUG

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

90 mg single dose

Intervention Type: DRUG

Other Intervention Names

Treatment A; Treatment B; Treatment C; Treatment D

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainard Fuhr, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

PAREXEL International GmbH, Berlin

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D5139C00003

Identifier Type: -

Identifier Source: org_study_id