NCT04104503

A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (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 the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

Detailed description

This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lu AF11167	Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)
DRUG	[14C]-Lu AF11167	single iv microdose administered as a 15 minutes infusion
DRUG	Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)	Single oral dose

Timeline

• Start date: 2019-09-17
• Primary completion: 2020-04-09
• Completion: 2020-04-09
• First posted: 2019-09-26
• Last updated: 2020-04-17

Locations

1 site across 1 country: United Kingdom