None listed
Conditions
Brief summary
Elinogrel is under the development for the treatment of patients with chronic coronary heart disease and acute coronary syndrome. Patient’s treated for these conditions are likely to be on a statin therapy such as atorvastatin in addition to other anticoagulants such as Elinogrel. Hence the need to investigate the potential drug interaction between Elinogrel and atorvastatin
Interventions
All participants will undergo a single sequence 3 treatment period as outlined below. Treatment periods are without overlap and with at least 5 days seperating each treatment period.
There will be three treatment phases.
Treatment 1 (Period 1 – 5 days)
Elingrel at a dose of 150 mg twice a day for 5 days.
Treatment 2 (Period 2 – 10 days)
atorvastatin at a dose of 40 mg once a day for the first 5 days followed by
Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 40 mg o
All participants will undergo a single sequence 3 treatment period as outlined below. Treatment periods are without overlap and with at least 5 days seperating each treatment period. There will be three treatment phases. Treatment 1 (Period 1 – 5 days) Elingrel at a dose of 150 mg twice a day for 5 days. Treatment 2 (Period 2 – 10 days) atorvastatin at a dose of 40 mg once a day for the first 5 days followed by Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 40 mg once a day for the last 5 days. There will be no evening dose on the last day. Treatment 3 (Period 3 – 10 days) atorvastatin at a dose of 80 mg once a day for the first 5 days followed by Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 80 mg once a day for the last 5 days. There will be no evening dose on the last day.
Sponsors
Novartis Pharmaceutical Pty Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female subjects aged 18 to 45 (inclusive), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline. All evaluations must be within normal range for age and gender, or considered ‘not clinically meaningful’ if outside the normal range. Body mass index (BMI) must be 18 – 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg. Vital signs (after 3 minutes in seated position) must be within stated ranges.
Exclusion criteria
PT (INR), aPTT, platelet count, bleeding time (in excess of 10 min), stool occult blood and microscopic hemoglobinuria, at screening or baseline are outside the normal range of the laboratory. INR below the lower limit of the local laboratory normal range isacceptable (but no lower than 0.9) at the investigators discretion. Facial or head trauma, intraocular hemorrhage, fractures within 30 days of Screening. History of any prior ischemic stroke or TIA within the last 5 years or intracranial hemorrhage, neoplasm, arteriovenous malformation, bleeding disorder or coagulation disorders which is considered clinically significant by the investigator. Known contraindication to the investigational compound, compound class (e.g. atorvastatin, clopidogrel glycoprotein IIb/IIIa inhibitors etc.). Smokers.
Outcome results
None listed