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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

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02202226

First Posted

July 25, 2014

Last Updated

March 4, 2015

Sponsor

H. Lundbeck A/S

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

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

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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