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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Ticagrelor with Platelet transfusion
Intervention: ASA (Drug)
4
Clopidogrel without Platelet transfusion
Intervention: ASA (Drug)
1
Ticagrelor with Platelet transfusion
Intervention: Ticagrelor (Drug)
2
Ticagrelor without Platelet transfusion
Intervention: Ticagrelor (Drug)
2
Ticagrelor without Platelet transfusion
Intervention: ASA (Drug)
3
Clopidogrel with Platelet transfusion
Intervention: Clopidogrel (Drug)
3
Clopidogrel with Platelet transfusion
Intervention: ASA (Drug)
4
Clopidogrel without Platelet transfusion
Intervention: Clopidogrel (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Secondary Outcomes
- Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Clopidogrel(Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h)
- Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables(up to 9 weeks)
- Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Ticagrelor(Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h)
- 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(Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h)