Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lu AF35700
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Men or women between 18 and 60 years (extremes included)
- BMI of ≤38
- Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
- Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
- PANSS total score ≤80
- Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
- Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit
Exclusion Criteria:
- The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
- The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
- The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
- The patient smokes >20 cigarettes per day
Other protocol-defined inclusion and exclusion criteria may apply
Sites / Locations
- PAREXEL Phase I Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lu AF35700 oral solution (1 mg/mL)
Matching placebo
Arm Description
Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
Oral solution
Outcomes
Primary Outcome Measures
Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
Change from baseline in AIMS, BARS and SAS Total score
Abnormal movement rating scale
Columbia Suicide Severity Rating Scale (C-SSRS)
Secondary Outcome Measures
Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime
Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152
Half-lives (t½) of Lu AF35700 and Lu AF36152
Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02202226
Brief Title
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
Official Title
Interventional, Randomised, Double-blind, Placebo-controlled, Sequential Group, Multiple Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF35700 in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 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 evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lu AF35700 oral solution (1 mg/mL)
Arm Type
Experimental
Arm Description
Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Oral solution
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
Time Frame
Screening to day 78 (up to 8 weeks after last dose)
Title
Change from baseline in AIMS, BARS and SAS Total score
Description
Abnormal movement rating scale
Time Frame
Baseline to day 21
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Sceening to day 78 (up to 8 weeks after last dose)
Secondary Outcome Measure Information:
Title
Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime
Time Frame
Day 21 in the dosing period
Title
Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152
Time Frame
Day 1 and 21 in the dosing period
Title
Half-lives (t½) of Lu AF35700 and Lu AF36152
Time Frame
Day 1 and 21 in the dosing period
Title
Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen
Time Frame
Day 14-21 in the dosing period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women between 18 and 60 years (extremes included)
BMI of ≤38
Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
PANSS total score ≤80
Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit
Exclusion Criteria:
The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
The patient smokes >20 cigarettes per day
Other protocol-defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H.Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
PAREXEL Phase I Unit
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
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Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
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