NCT06277609

A Trial Investigating Lu AF28996 in Healthy Adult Participants

Interventional, Open-label, Repeated Single-dose Trial Investigating the Effects of Enzyme Inhibition on the Pharmacokinetic Profile of Lu AF28996 and Its Metabolites in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.

Detailed description

The study has 2 parts: Part A and Part B. Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors. Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Lu AF28996	Capsule
DRUG	Acetylsalicylic Acid	Tablet
DRUG	Mefenamic Acid	Tablet
DRUG	Amoxicillin/clavulanic acid	Tablet

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-05-19
• Completion: 2024-05-19
• First posted: 2024-02-26
• Last updated: 2024-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study