Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202226
• Other study ID #: 14754A
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2014
• Last updated: March 4, 2015
• Start date: January 2013

Study information

• Verified date: March 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lu AF35700

• Placebo

Locations

Country	Name	City	State
United States	PAREXEL Phase I Unit	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)		Screening to day 78 (up to 8 weeks after last dose)	Yes
Primary	Change from baseline in AIMS, BARS and SAS Total score	Abnormal movement rating scale	Baseline to day 21	Yes
Primary	Columbia Suicide Severity Rating Scale (C-SSRS)		Sceening to day 78 (up to 8 weeks after last dose)	Yes
Secondary	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		Day 21 in the dosing period	No
Secondary	Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152		Day 1 and 21 in the dosing period	No
Secondary	Half-lives (t½) of Lu AF35700 and Lu AF36152		Day 1 and 21 in the dosing period	No
Secondary	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		Day 14-21 in the dosing period	No