Clinical trial NCT01887626: Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability Heathy Volunteers
Keywords: Phase 1, pharmacokinetic, safety, Ticagrelor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
timeFrame: 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
measure: Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
timeFrame: 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
measure: Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
timeFrame: 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
measure: Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
timeFrame: 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:
measure: Description of the safety profile in terms of adverse events (AE)
timeFrame: From first dose through to the follow-up visit.
measure: Description of the safety profile in terms of laboratory variables
timeFrame: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
measure: Description of the safety profile in terms of vital signs
timeFrame: 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
measure: Description of the safety profile in terms of physical examination findings
timeFrame: Physical examination at screening, pre-dose, Day 3 and follow-up
measure: Description of the safety profile in terms of Electrocardiogram (ECG)
timeFrame: ECGs at screening, Day 3 and follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca, Wilmington, US
name: Judith Hsia, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Mölndal, Sweden
name: Mirjana Kujacic, MD
role: STUDY_CHAIR
affiliation: Quintiles London, United Kingdom
name: Saeed Kahn, MBBS
role: PRINCIPAL_INVESTIGATOR
References: