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Acasti IND Cleared by FDA

Hires Quintiles to run PK study

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Acasti Pharma‘s IND has been cleared by the FDA, allowing the company to initiate a pharmacokinetic (PK) trial of CaPre in the U.S. Following the clearance, Acasti engaged Quintiles to conduct its PK study.

The PK trial is an open-label, randomized, multiple-dose, single-center, parallel-design study that will evaluate blood profiles and bioavailability of omega-3 phospholipids on 42 healthy volunteers taking single and multiple daily oral doses of 1, 2 and 4 grams of CaPre. CaPre is a highly purified omega-3 phospholipid concentrate derived from krill oil and is being developed to help prevent and treat hypertriglyceridemia.

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