A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2020-04-09

Brief Summary

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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

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

Group Type EXPERIMENTAL

Lu AF11167

Intervention Type DRUG

Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)

Part B group 1

Treatment period 1: Fasted + iv;

Treatment period 2: Fasted;

Treatment period 3: High-fat meal

Group Type EXPERIMENTAL

[14C]-Lu AF11167

Intervention Type DRUG

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)

Intervention Type DRUG

Single oral dose

Part B group 2

Treatment period 1: High-fat meal;

Treatment period 2: Fasted + iv;

Treatment period 3: Fasted

Group Type EXPERIMENTAL

[14C]-Lu AF11167

Intervention Type DRUG

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)

Intervention Type DRUG

Single oral dose

Part B group 3

Treatment period 1: Fasted;

Treatment period 2: High-fat meal;

Treatment period 3: Fasted + iv

Group Type EXPERIMENTAL

[14C]-Lu AF11167

Intervention Type DRUG

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)

Intervention Type DRUG

Single oral dose

Interventions

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Lu AF11167

Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)

Intervention Type DRUG

[14C]-Lu AF11167

single iv microdose administered as a 15 minutes infusion

Intervention Type DRUG

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

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes