Back to resultsPharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lu AF11167
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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.
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Period A
Treatment Period B
Arm Description
1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167
Food interaction and multiple dosing of Lu AF11167
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02260830
Brief Title
Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Period A
Arm Type
Experimental
Arm Description
1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167
Arm Title
Treatment Period B
Arm Type
Experimental
Arm Description
Food interaction and multiple dosing of Lu AF11167
Intervention Type
Drug
Intervention Name(s)
Lu AF11167
Primary Outcome Measure Information:
Title
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.
Description
Composite analysis
Time Frame
0-48 hours
Title
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.
Description
Composite analysis
Time Frame
Up to 60 hours post dose on day 7
Secondary Outcome Measure Information:
Title
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).
Description
Composite analysis
Time Frame
0-48 HOurs
Title
PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax.
Description
Composite analysis
Time Frame
Up to 60 hours post dose day 7
Other Pre-specified Outcome Measures:
Title
Number of adverse events
Time Frame
Up to 70 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via LundbeckClinicalTrials@Lundbeck.com
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Quotient Clinical
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167
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