cardiovascular events thrombosis
Conditions
Interventions
Active substance: E5555
1 group with 2 dosing arms
arm 1
Period 1: single dose of 100 mg E5555
Period 2: single dose of 100 mg E5555 and a daily dose of 360 mg
diltiazemduring during 14 days
Arm 2
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy males or females 18-55 years non smoker or have not used nicotine-containing products for at least 3 months prior to first dosing BMI between 18.0 and 32.0 kg/m2 no known personal or family medical history of bleeding disorders, or spontaneous gum bleeding by history
Exclusion criteria
Exclusion criteria: 1. A family history, past medical history or clinical signs and symptoms of a bleeding diathesis 2. History of any medical condition, which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc 3. Subjects with a history of spontaneous gum bleeding or clinical signs and symptoms on physical exam 4. Clinically significant ocular disease or untreated visual or ocular symptoms 5. Clinically significant abnormal ECGs prior to dosing (Screening or Baselines) including a QT interval corrected for heart rate using Bazett*s formula (QTcB) > 450 ms for males and > 470 ms for females 6. Any history or past medical condition that will result in QTc prolongation or tachyarrhythmia such as Torsades de Pointes (includes hypokalemia, known family history of long QT syndrome, or any other known risk factors for Torsades de Pointes) 7. Subjects with renal insufficiency (i.e., a glomerular filtration rate (GFR) 390,000 per mL at Screening or Baseline Period 1 9. Abnormal (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Safety Tolerability Pharmacodynamics | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed