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CompletedNCT02202226Updated Mar 6, 2015

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

A Phase 1 interventional study of Lu AF35700 and Placebo in Schizophrenia, sponsored by H. Lundbeck A/S. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 96 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Lu AF35700 oral solution (1 mg/mL)

    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

  • Placebo comparator
    Matching placebo

    Oral solution

    Drug: Placebo

Interventions

  • DrugLu AF35700
  • DrugPlacebo
06

What researchers measure

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

    Abnormal movement rating scale

    Time frame: Baseline to day 21

  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

07

Study locations

1 site
  • PAREXEL Phase I Unit
    Glendale, California 91206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02202226
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Jul 28, 2014
Start date
Jan 2013
Primary completion
Feb 2015
Last update
Mar 6, 2015

Study contacts

Email contact via H.Lundbeck A/S
study director · LundbeckClinicalTrials@Lundbeck.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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