Safety and Tolerability of BI 409306 in Patients With Schizophrenia

A Phase 1 study testing BI 409306 in people with Schizophrenia, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia
What is being tested?: BI 409306
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2013to 5 Dec 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

1289.18.1 Boehringer Ingelheim Investigational Site
Austin, Texas

Other trials in United States

About this study

Official title: 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)

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.

Conditions: Schizophrenia
Being tested: Placebo, BI 409306
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
matching placebo
BI 409306Drug
BI 409306

Study groups in NCT01892384
Study group	Role	What they receive
BI 409306 dose 1	Experimental	low dose, once daily Receives: Drug: BI 409306
BI 409306 dose 2	Experimental	medium dose, once daily Receives: Drug: BI 409306
BI 409306 dose 3	Experimental	high dose, once daily Receives: Drug: BI 409306
Placebo	Placebo comparator	placebo, once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Drug-related Adverse Events
Number of participants with drug-related adverse events.
Measured: From first drug administration until 30 days after last drug administration, up to 44 days.

Secondary outcomes (6)

Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)
Maximum measured concentration of BI 409306 in plasma after single dose (Cmax) is presented.
Measured: 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)
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is presented.
Measured: 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 from dosing to maximum measured concentration of BI 409306 in plasma after single dose (tmax) is presented.
Measured: 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 from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is presented.
Measured: 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)
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.
Measured: 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)
Area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss) is presented.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 20135 Dec 2013

First posted4 Jul 2013 (estimated)
Study start28 Jun 2013
Primary completion5 Dec 2013
Study completion5 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01892384
Sponsor's protocol ID: 1289.18
Status last verified: Apr 2024
First submitted: 1 Jul 2013
Last updated: 25 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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

Publications

Brown D, Daniels K, Pichereau S, Sand M. A Phase IC Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Cognitive Outcomes of BI 409306 in Patients with Mild-to-Moderate Schizophrenia. Neurol Ther. 2018 Jun;7(1):129-139. doi: 10.1007/s40120-017-0085-5. Epub 2017 Nov 24.
PubMed 29177699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01892384
Acronym / sponsor ID: 1289.18
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Jun 2013 (actual)
Primary completion: 5 Dec 2013 (actual)
Study completion: 5 Dec 2013 (actual)
First posted: 4 Jul 2013 (estimated)
Results: Posted 8 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 409306 dose 1	Experimental	Drug: BI 409306low dose, once daily
BI 409306 dose 2	Experimental	Drug: BI 409306medium dose, once daily
BI 409306 dose 3	Experimental	Drug: BI 409306high dose, once daily
Placebo	Placebo comparator	Drug: Placeboplacebo, once daily

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)) with the following clinical features:
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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebomatching placebo	Drug	Placebo
BI 409306BI 409306	Drug	BI 409306 dose 1, BI 409306 dose 2, BI 409306 dose 3

Primary outcome

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.

6 secondary outcomes

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 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.
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 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.
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 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.

Results and safety

Results posted to the registry on 8 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 409306 25mg	10	9
BI 409306 50mg	10	9
BI 409306 100mg	10	10
Placebo	10	10

Primary outcome: 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. Unit: Participants

Measure	BI 409306 25mg n = 10	BI 409306 50mg n = 10	BI 409306 100mg n = 10	Placebo n = 10
Value	1	3	2	3

Population analysed: Treated set which included all randomized patients who received at least one dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 409306 25mg	0 of 10 (0%)	4 of 10 (40%)	Not reported
BI 409306 50mg	0 of 10 (0%)	9 of 10 (90%)	Not reported
BI 409306 100mg	0 of 10 (0%)	6 of 10 (60%)	Not reported
Placebo	0 of 10 (0%)	4 of 10 (40%)	Not reported
Total.	0 of 40 (0%)	23 of 40 (57.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29177699Brown D, Daniels K, Pichereau S, Sand M. A Phase IC Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Cognitive Outcomes of BI 409306 in Patients with Mild-to-Moderate Schizophrenia. Neurol Ther. 2018 Jun;7(1):129-139. doi: 10.1007/s40120-017-0085-5. Epub 2017 Nov 24.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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

Related trials for Schizophrenia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 409306 in people with Schizophrenia, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01892384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.