NCT03608319

Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions

Phase 1, Open-Label, Randomized, 3-Way Crossover Relative Bioavailability of A4250 in Healthy Adult Subjects Under Fasting and Fed Conditions and When Sprinkled on Applesauce

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Albireo · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.

Detailed description

This is an open-label, randomized, 3-way crossover, food-effect and sprinkle study. On Day 1 of each period, subjects will receive a single oral dose of A4250 under 1 of 3 conditions: fasting, following a high-fat, high-calorie breakfast, or sprinkled on applesauce. Subjects will receive A4250 under each condition on one occasion. Blood samples for PK analysis will be collected for 18 hours following each study drug administration. There will be a washout period of at least 7 days between doses. Study participants will be contacted approximately 14 days after the last study drug administration to determine if any adverse event (AE) has occurred since the last study visit.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	A4250	9.6 mg

Timeline

• Start date: 2018-07-05
• Primary completion: 2018-08-05
• Completion: 2018-08-18
• First posted: 2018-07-31
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study