Clinical trial NCT01744288: Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets
Official title: A Open Label, Randomized, Crossover and Potential Parallel, Single Dose Study of Ticagrelor 180 mg and Acetylsalicylic Acid (ASA) in Healthy Volunteers Followed by Autologous in Vivo Platelet Transfusion to Determine the Effects of Platelet Supplementation on the Reversibility of Platelet Inhibition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inhibition on Platelet Aggregation
Keywords: Phase 1 Safety ,
pharmacodynamic,
Ticagrelor,
Clopidogrel,
Platelets
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 258
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 see if platelet transfusion stop or lessen the effect of the drug on platelets

Detailed description: A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and/or female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, electrocardiogram (ECG) perform
* Have a body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg

Exclusion Criteria:

* ADP induced platelet aggregation \<60% prior to platelet apheresis
* History of peptic ulcer disease Healthy volunteers with a propensity to bleed (eg, due to recent trauma, recent surgery, active or recent gastrointestinal bleeding or moderate hepatic impairment)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Current smokers, those who have smoked or used nicotine products within the previous 3 months and those who tested positive for cotinine at screening or at admission to the study center

Primary outcomes:
measure: Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Ticagrelor
timeFrame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Secondary outcomes:
measure: Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Ticagrelor
timeFrame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
measure: Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Clopidogrel
timeFrame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
measure: Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Clopidogrel
timeFrame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
measure: Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca Wilmington US
name: Glenn Carlson, MD
role: STUDY_CHAIR
affiliation: Overland Park US, Quintiles, Inc
name: Phil Leese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilmington, US AstraZeneca
name: Judi Hsia, MD
role: STUDY_DIRECTOR
References: