Status:

COMPLETED

A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Healthy

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief 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). T...

Eligibility Criteria

Inclusion

  • Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
  • (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status

Exclusion

  • The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product
  • Other in- and exclusion criteria may apply

Key Trial Info

Start Date :

September 17 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 9 2020

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT04104503

Start Date

September 17 2019

End Date

April 9 2020

Last Update

April 17 2020

Active Locations (1)

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Quotient

Nottingham, United Kingdom