Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lu AF11167

• Registration Number: NCT02260830
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Period A	Lu AF11167	1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167
Treatment Period B	Lu AF11167	Food interaction and multiple dosing of Lu AF11167

Primary Outcome Measures

Name	Time	Method
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.	0-48 hours	Composite analysis
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.	Up to 60 hours post dose on day 7	Composite analysis

Secondary Outcome Measures

Name	Time	Method
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).	0-48 HOurs	Composite analysis
PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax.	Up to 60 hours post dose day 7	Composite analysis

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom