A Phase 1, Randomized, Open-Label Study to Assess the Bioequivalence of Trofinetide as a Ready-to-Use Oral Solution and Constituted Powder for Oral Solution in Healthy Adults

Key Points

• The study aims to evaluate the bioequivalence of trofinetide delivered as a ready-to-use oral solution compared to a constituted powder for oral solution.
• Phase 1, randomized, open-label trial design
• Comparison of ready-to-use oral solution and constituted powder forms of trofinetide
• Assessment of bioavailability and potential adverse events
• Bioequivalence between the two forms of trofinetide was demonstrated
• TPOS showed no difference in bioavailability when constituted with varying water volumes
• No unexpected adverse events were reported during the trial