Clinical trial NCT02202226: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
timeFrame: Screening to day 78 (up to 8 weeks after last dose)
measure: Change from baseline in AIMS, BARS and SAS Total score
timeFrame: Baseline to day 21
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Sceening to day 78 (up to 8 weeks after last dose)
Secondary outcomes:
measure: 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
timeFrame: Day 21 in the dosing period
measure: Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152
timeFrame: Day 1 and 21 in the dosing period
measure: Half-lives (t½) of Lu AF35700 and Lu AF36152
timeFrame: Day 1 and 21 in the dosing period
measure: 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
timeFrame: Day 14-21 in the dosing period
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL Phase I Unit
state: California
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H.Lundbeck A/S
role: STUDY_DIRECTOR
References: