Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Brief Summary

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The purpose of this study is to investigate the pharmacokinetic (PK) properties of various modified release tablet formulations of Lu AF11167 (Part A) and to investigate the pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a fed and fasted state and following multiple dosing (Part B).

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Period A

1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167

Group Type EXPERIMENTAL

Lu AF11167

Intervention Type DRUG

Treatment Period B

Food interaction and multiple dosing of Lu AF11167

Group Type EXPERIMENTAL

Lu AF11167

Intervention Type DRUG

Interventions

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Lu AF11167

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2.
* Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes