Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
Completed · Phase 1
Conditions studied: Hypertriglyceridemia
In brief
This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin
Key facts
- Study ID
- NCT02859129
- Run by
- AstraZeneca
- People needed
- 114
- Starts
- 2013-09-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2016-08-17
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female (non-childbearing potential)
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
- Non-smoker
- Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs
You may not qualify if…
- mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
- History or presence of myopathy and/or hypothyroidism.
- History or presence of transaminase elevations
- History or presence of hypersensitivity or idiosyncratic reaction to rosuvastatin, to other HMG-CoA reductase inhibitors, to Epanova™, to Vascepa®, or to related compounds
- Known sensitivity or allergy to soybeans, fish, and/or shellfish.
- Has consumed fish within 7 days prior to check-in.
- Female subjects who are pregnant or lactating.
- Positive urine drug and alcohol results at screening or check-in.
- Positive urine cotinine at screening and check-in
- Use of any drugs known to be inducers of CYP enzymes and/or P-gp
- Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
- Plasma donation within 7 days prior to the first dose of study medication.
- Participation in another clinical trial within 28 days prior to the first dose of study medication.
Where it is running
- Celerion — Neptune City, New Jersey, United States
Full record on ClinicalTrials.gov
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