NCT01486433

An Open-Label, Randomized, 2-Way Crossover Study to Evaluate the Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

Completed Phase 1 Last updated 29 April 2015

What this trial tests

Phase 1 trial testing Simvastatin in Hypertriglyceridemia in 52 participants. Completed in 1 March 2012.

Timeline

1 November 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	1 November 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across United States

Drugs / interventions tested

• Simvastatin (simvastatin) — full drug profile →
• acetylsalicylic acid (ASA) — full drug profile →
• omefas — full drug profile →

Conditions studied

• Hypertriglyceridemia — all drugs for Hypertriglyceridemia →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Hypertriglyceridemia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Area under the plasma concentration versus time curve (AUC0-tau)
  Time frame: 14 days
  Area under the plasma concentration versus time curve (AUC0-tau)for simvastatin and beta- hydroxysimvastatin acid, measured over the 24 hour period after the 14th dose
• Concentration at the end of a dosing interval (Cmax,ss) for simvastatin and beta- hydroxysimvastatin acid,
  Time frame: 14 days
  Maximum measured plasma concentration for simvastatin and beta- hydroxysimvastatin acid,during the 0-24 hour dosing interval for the 14th simvastatin dose (Day 14)measured over the 24 hour period after the 14th dose.

Sponsor's own description

The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessment of pharmacokinetic interaction between omega-3 carboxylic acids and the statins rosuvastatin and simvastatin: Results of 2 phase I studies in healthy volunteers.
   Offman E, Davidson M, Nilsson C. · · 2017 · cited 2× · PMID 28506390 · DOI 10.1016/j.jacl.2017.03.017
2. No Effect of Omega-3 Carboxylic Acids on Pharmacokinetics/Pharmacodynamics of Warfarin or on Platelet Function When Co-administered with Acetylsalicylic Acid: Results of Two Phase I Studies in Healthy Volunteers.
   Offman E, Davidson M, Nilsson C. · · 2017 · cited 1× · PMID 28197979 · DOI 10.1007/s40256-017-0217-4