The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. It is delivered subcutaneously via pre-filled syringe.
Key points:
• Throughout the development cycle of dulaglutide, model‐informed drug development (MIDD) was applied to facilitate and accelerate decision‐making.
• A novel MIDD approach was adopted to evaluate drug-drug interactions (DDI), due to changes in gastric emptying.
• Acetaminophen PK from previous gastric emptying studies covering a wide range of dulaglutide doses was used to characterize the extent of gastric-emptying delay (GED) related to 4.5 mg of dulaglutide.
• The extent of GED was then applied to physiologically based pharmacokinetic (PBPK) models of individual 10 commonly co-administered oral agents to simulate effect of delayed gastric emptying on their PK profiles and inform drug labeling.
Speakers
- Lai San Tham PharmD. – Principal Research Scientist, Eli Lilly
- Maria M. Posada PhD – Principal Research Scientist, Eli Lilly