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Completed

NCT Number: NCT02202226

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Phase I Unit

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AF35700

Drug

Placebo

Drug

Primary outcomes

  1. 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)

  2. Change from baseline in AIMS, BARS and SAS Total score

    Time frame: Baseline to day 21

    Abnormal movement rating scale

  3. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Sceening to day 78 (up to 8 weeks after last dose)

Secondary outcomes

  1. 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

  2. Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152

    Time frame: Day 1 and 21 in the dosing period

  3. Half-lives (t½) of Lu AF35700 and Lu AF36152

    Time frame: Day 1 and 21 in the dosing period

  4. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
First posted
Jul 28, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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