A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04104503

18153A

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Part A

Experimental group

Treatment:

Drug: Lu AF11167

Part B group 1

Experimental group

Description:

Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal

Treatment:

Drug: [14C]-Lu AF11167

Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Part B group 2

Experimental group

Description:

Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted

Treatment:

Drug: [14C]-Lu AF11167

Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Part B group 3

Experimental group

Description:

Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv

Treatment:

Drug: [14C]-Lu AF11167

Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)