A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-Lu AF11167; Drug: Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

• Registration Number: NCT04104503
• Lead Sponsor: H. Lundbeck A/S

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). 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.

Study Timeline

• Study Start: 2019-09-17
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Status Verified: 2020-04
• Primary Completion: 2020-04-09
• Study Completion: 2020-04-09
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B group 3	[14C]-Lu AF11167	Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv
Part B group 1	[14C]-Lu AF11167	Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal
Part B group 1	Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)	Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal
Part B group 2	[14C]-Lu AF11167	Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted
Part B group 2	Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)	Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted
Part A	Lu AF11167	-
Part B group 3	Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)	Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv

Primary Outcome Measures

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

Trial Locations

Locations (1)

Quotient; 🇬🇧 Nottingham, United Kingdom