A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104503
• Other study ID #: 18153A
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: April 9, 2020

Study information

• Verified date: April 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Lu AF11167	Maximum observed plasma concentration	From 0 to 48 hours
Primary	AUC(0-inf) of Lu AF11167	Area under the plasma concentration time curve from zero to infinity	From 0 to 48 hours
Primary	Relative bioavailability F(rel) of Lu AF11167	F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)	From 0 to 48 hours
Primary	Absolute bioavailability F(abs) of Lu AF11167	F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)	From 0 to 48 hours