Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260830
• Other study ID #: 15911A
• Secondary ID: 2013-004887-77
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2014
• Last updated: March 4, 2015
• Start date: August 2014

Study information

• Verified date: March 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lu AF11167

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events		Up to 70 days	Yes
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No