To determine whether a pharmacokinetic drug-drug interaction occurs between atorvastatin and elinogrel.
- Conditions
- chronic coronary heart disease (CHD)Cardiovascular - Coronary heart disease
- Registration Number
- ACTRN12611000315910
- Lead Sponsor
- ovartis Pharmaceutical Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetics of atorvastatin following once a day dosing alone and in combination with elinogrel in healthy volunteers.[PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 2 to 24 hrs after the morning dose];To characterize the pharmacokinetics of elinogrel following twice a day dosing alone and in combination with atorvastatin in healthy volunteers.[PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 3 to 24 hrs after the morning dose]
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of elinogrel and atorvastatin co-administration in healthy volunteers[PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 2 and 3 to 24 hrs after the morning dose]