Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Lu AF11167

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260830

2013-004887-77 (EudraCT Number)

15911A

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.
• Other pre-defined inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Treatment Period A

Experimental group

Description:

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

Treatment:

Drug: Lu AF11167

Treatment Period B

Experimental group

Description:

Food interaction and multiple dosing of Lu AF11167

Treatment:

Drug: Lu AF11167