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

NCT02202226 — Phase 1, Completed, 96 participants, H. Lundbeck A/S

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02202226
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	96 (Actual)
Sponsor	H. Lundbeck A/S (Industry)
Conditions	Schizophrenia
Interventions	Lu AF35700, Placebo (Drug)
Dates	start 2013-01-01, primary completion 2015-02-01, first posted 2014-07-28, last updated 2015-03-06
Locations	1 site in United States

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Lu AF35700 oral solution (1 mg/mL)	Experimental	Drug: 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.
Matching placebo	Placebo comparator	Drug: Placebo	Oral solution

Lu AF35700 (Drug)
Placebo (Drug)

+Outcome measures

Primary outcomes

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)]
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)]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
PAREXEL Phase I Unit	Glendale, California	United States

+Investigators

Email contact via H.Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com