- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892384
Safety and Tolerability of BI 409306 in Patients With Schizophrenia
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Patients With Schizophrenia (Randomized, Parallel-group, Double-blind, Placebo-controlled Study)
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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Austin, Texas, United States
- 1289.18.1 Boehringer Ingelheim Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)) with the following clinical features:
- Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks.
- Maintained on current antipsychotic medications and current dose for at least 8 weeks.
- Have no more than a moderate severity rating on hallucinations and delusions (e.g. Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item score < or =4).
- Have no more than a moderate severity rating on positive formal thought disorder (e.g. BPRS Conceptual Disorganization item score < or =4).
- Have no more than a moderate severity rating on negative symptoms (Positive and Negative Syndrome Scale negative syndrome total score <15).
- Have a minimal level of extrapyramidal symptoms (e.g. Simpson-Angus Scale total score < 6) and depressive symptoms (e.g. Calgary Depression Scale total score < 10).
- Male or female patients age > or = 18 and < or =55 years.
- Patients must exhibit reliability and physiologic capability to comply with all protocol procedures.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written consent as well.
Exclusion criteria:
- Patient treated with more than one antipsychotic or not stabilized on antipsychotic treatment, or having had electroconvulsive therapy within the last 30 days
- Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator.
- Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
- Any finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal and of clinical relevance in the judgment of the investigator.
- Any evidence of a clinically relevant concomitant disease.
- History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological or hormonal disorders.
- Female patients that are of child-bearing potential or currently breastfeeding.
- Known history, or new diagnosis per screening labs, of HIV infection.
- History of neurologic (e.g. stroke, seizure without a clear and resolved etiology, concussion accompanying loss of consciousness) or psychiatric condition that the investigator deems may interfere with interpretability of data
- History of malignancy within the last 5 years, except for basal cell carcinoma.
- Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period.
- Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this clinical trial.
- Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening.
- Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 409306 dose 1
low dose, once daily
|
BI 409306
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Experimental: BI 409306 dose 2
medium dose, once daily
|
BI 409306
|
Experimental: BI 409306 dose 3
high dose, once daily
|
BI 409306
|
Placebo Comparator: Placebo
placebo, once daily
|
matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Drug-related Adverse Events
Time Frame: From first drug administration until 30 days after last drug administration, up to 44 days.
|
Number of participants with drug-related adverse events.
|
From first drug administration until 30 days after last drug administration, up to 44 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)
Time Frame: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration
|
Maximum measured concentration of BI 409306 in plasma after single dose (Cmax) is presented.
|
2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration
|
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)
Time Frame: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is presented.
|
2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Tmax)
Time Frame: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
|
Time from dosing to maximum measured concentration of BI 409306 in plasma after single dose (tmax) is presented.
|
2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
|
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)
Time Frame: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is presented.
|
2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After a Single Dose (AUC0-infinity)
Time Frame: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
|
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after a single dose (AUC0-infinity) is presented.
|
2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
|
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)
Time Frame: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss) is presented.
|
2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1289.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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