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

NCT ID: NCT01887626

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Bioavailability Heathy Volunteers

Keywords

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Phase 1, pharmacokinetic, safety, Ticagrelor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Ticagrelor 90 mg as a whole tablet

Group Type EXPERIMENTAL

Ticagrelor 90 mg whole tablet

Intervention Type DRUG

Ticagrelor 90 mg whole tablet administered as a single oral dose

B

Ticagrelor 90 mg tablet crushed and suspended in water

Group Type EXPERIMENTAL

Ticagrelor 90 mg tablet crushed

Intervention Type DRUG

Ticagrelor 90 mg crushed and suspended in water

C

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

Group Type EXPERIMENTAL

Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube

Intervention Type DRUG

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

Interventions

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Ticagrelor 90 mg whole tablet

Ticagrelor 90 mg whole tablet administered as a single oral dose

Intervention Type DRUG

Ticagrelor 90 mg tablet crushed

Ticagrelor 90 mg crushed and suspended in water

Intervention Type DRUG

Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Hsia, MD

Role: STUDY_DIRECTOR

AstraZeneca, Wilmington, US

Mirjana Kujacic, MD

Role: STUDY_CHAIR

AstraZeneca Mölndal, Sweden

Saeed Kahn, MBBS

Role: PRINCIPAL_INVESTIGATOR

Quintiles London, United Kingdom

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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India United Kingdom

Other Identifiers

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D5130C00076

Identifier Type: -

Identifier Source: org_study_id