Study to assess the bioavailability of ticagrelor OD tablet vs. IR tablet

Study identifier:D5139C00003

ClinicalTrials.gov identifier:NCT02400333

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Bioavailability, Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

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

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 Jun 2015

Primary Completion Date: 31 Jul 2015

Study Completion Date: 31 Jul 2015

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Sept 2017 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: 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	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water 90 mg single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water 90 mg single dose Other Name: Treatment B Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube 90 mg single dose Other Name: Treatment C Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water 90 mg single dose Other Name: Treatment D
Experimental: 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	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water 90 mg single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water 90 mg single dose Other Name: Treatment B Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube 90 mg single dose Other Name: Treatment C Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water 90 mg single dose Other Name: Treatment D
Experimental: 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	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water 90 mg single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water 90 mg single dose Other Name: Treatment B Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube 90 mg single dose Other Name: Treatment C Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water 90 mg single dose Other Name: Treatment D
Experimental: 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	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water 90 mg single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water 90 mg single dose Other Name: Treatment B Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube 90 mg single dose Other Name: Treatment C Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water 90 mg single dose Other Name: Treatment D

Documents available

d5139c00003_csp_amendment1_redacted
Download
Pharmacokinetic profiles of ticagrelor orodispersible tables in healthy Western and Japanese subjects; Clin Drug Investig Epub online 30 Aug 2017
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

PAREXEL International Call Center

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