- Has had treatment with any other new molecular entity (investigational drug) during the previous 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer), prior to the first dose of current study medication. For the purposes of this study, a new molecular entity is defined as any compound that has not yet reached Phase 3 development. The washout is defined from last dose of study medication in the previous study until the first dose of study drug.