To determine whether a pharmacokinetic drug-drug interaction occurs between atorvastatin and elinogrel.
An open-label, single sequence study to assess the potential pharmacokinetic drug-drug interaction of elinogrel and atorvastatin at steady-state in healthy adult subjects
Novartis Pharmaceutical Pty Limited
28 participants
Apr 7, 2011
Interventional
Conditions
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
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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.
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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 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.
Locations(1)
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ACTRN12611000315910