Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Eicosapentaenoic acid ethyl ester; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.