NCT05028673

A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

Interventional, Randomized, Open-Label, Crossover, Single-Dose, Relative Bioavailability Study Comparing Two Pharmaceutical Formulations of Lu AG06466 and Investigating the Food Effect on Lu AG06466 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.

Detailed description

This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lu AG06466 Capsule	Hard capsule
DRUG	Lu AG06466 Tablet	Film-coated tablet
DRUG	Antacid	Oral suspension

Timeline

• Start date: 2021-08-23
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2021-08-31
• Last updated: 2022-01-21

Locations

1 site across 1 country: United Kingdom