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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Lu AF35700

• Registration Number: NCT02202226
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Placebo	Oral solution
Lu AF35700 oral solution (1 mg/mL)	Lu AF35700	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in AIMS, BARS and SAS Total score	Baseline to day 21	Abnormal movement rating scale
Columbia Suicide Severity Rating Scale (C-SSRS)	Sceening to day 78 (up to 8 weeks after last dose)
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)

Secondary Outcome Measures

Name	Time	Method
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
Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152	Day 1 and 21 in the dosing period
Half-lives (t½) of Lu AF35700 and Lu AF36152	Day 1 and 21 in the dosing period
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

Trial Locations

Locations (1)

PAREXEL Phase I Unit; 🇺🇸 Glendale, California, United States