Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioavailability Heathy Volunteers

Treatments: Drug: Ticagrelor 90 mg whole tablet; Drug: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube; Drug: Ticagrelor 90 mg tablet crushed

Study type: Interventional

Funder types: Industry

Identifiers

NCT01887626

D5130C00076

Details and patient eligibility

About

Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

A

Experimental group

Description:

Ticagrelor 90 mg as a whole tablet

Treatment:

Drug: Ticagrelor 90 mg whole tablet

B

Experimental group

Description:

Ticagrelor 90 mg tablet crushed and suspended in water

Treatment:

Drug: Ticagrelor 90 mg tablet crushed

C

Experimental group

Description:

Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach

Treatment:

Drug: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube