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

NCT02202226 | Completed Phase 1

• 1 other identifier: 14754A
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• 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

  Abnormal movement rating scale

  Baseline to day 21

• Columbia Suicide Severity Rating Scale (C-SSRS)

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

Secondary Outcomes (4)

• 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

Study Arms (2)

Lu AF35700 oral solution (1 mg/mL)

EXPERIMENTAL

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.

Drug: Lu AF35700

Matching placebo

PLACEBO COMPARATOR

Oral solution

Drug: Placebo

Interventions

Lu AF35700 DRUG

Lu AF35700 oral solution (1 mg/mL)

Placebo DRUG

Matching placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

PAREXEL Phase I Unit

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lu AF35700

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Email contact via H.Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 28, 2014
• Study Start: January 1, 2013
• Primary Completion: February 1, 2015
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)