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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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