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Completed

NCT Number: NCT01887626

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 90 mg whole tablet

Drug

Ticagrelor 90 mg whole tablet administered as a single oral dose

Ticagrelor 90 mg tablet crushed

Drug

Ticagrelor 90 mg crushed and suspended in water

Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube

Drug

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

Primary outcomes

  1. Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor

    Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

  2. Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor

    Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

  3. Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor

    Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

  4. Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor

    Time frame: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

Secondary outcomes

  1. Description of the safety profile in terms of adverse events (AE)

    Time frame: From first dose through to the follow-up visit.

  2. Description of the safety profile in terms of laboratory variables

    Time frame: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up

  3. Description of the safety profile in terms of vital signs

    Time frame: Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up

  4. Description of the safety profile in terms of physical examination findings

    Time frame: Physical examination at screening, pre-dose, Day 3 and follow-up

  5. Description of the safety profile in terms of Electrocardiogram (ECG)

    Time frame: ECGs at screening, Day 3 and follow-up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2013
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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