Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

Interventional, Open-label, Part Fixed Sequence, Part-randomised Study Investigating the Pharmacokinetic Properties of up to 6 Prototype Modified Release Tablet Formulations of Lu AF11167 in Healthy Young Subjects

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lu AF11167

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Period A; 1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167	Drug: Lu AF11167
Experimental: Treatment Period B; Food interaction and multiple dosing of Lu AF11167	Drug: Lu AF11167

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F.	Composite analysis	0-48 hours
PK parameters for Lu AF11167 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI (accumulation index), Cmax, Cpre, CL/F, t½, tmax and Vz/F.	Composite analysis	Up to 60 hours post dose on day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters for Lu AF36201 estimated from the single dose treatment periods in Part A and B: Cmax, AUC0-inf, AUC0-t, AUC%extr, t½, tlag and tmax, MR (metabolic ratio).	Composite analysis	0-48 HOurs
PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax.	Composite analysis	Up to 60 hours post dose day 7

Other Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	Up to 70 days

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via LundbeckClinicalTrials@Lundbeck.com, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 15911A; 2013-004887-77 (EudraCT Number)