← Back to Search

NMDA receptor antagonist

BI 409306 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Awards & highlights

Study Summary

This study is evaluating whether a drug may help reduce the cognitive deficits associated with ketamine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4:20 and 5:06 hours:minutes after first drug administration in each treatment period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine
Secondary outcome measures
Rapid Visual Information Processing A' Prime (RVPA) on Ketamine
Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine

Side effects data

From 2017 Phase 2 trial • 128 Patients • NCT02240693
10%
Rash
5%
Bradycardia
5%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 409306 25 mg Twice Daily (BID)
BI 409306 10 Milligram (mg) Once Daily (QD)
BI 409306 25 mg QD
BI 409306 50 mg QD
Placebo Matching BI 409306

Trial Design

18Treatment groups
Experimental Treatment
Group I: Treatment sequence: T3-T2-RExperimental Treatment3 Interventions
Group II: Treatment sequence: T3-T1-RExperimental Treatment3 Interventions
Group III: Treatment sequence: T3-R-T2Experimental Treatment3 Interventions
Group IV: Treatment sequence: T3-R-T1Experimental Treatment3 Interventions
Group V: Treatment sequence: T2-T3-RExperimental Treatment3 Interventions
Group VI: Treatment sequence: T2-T1-RExperimental Treatment3 Interventions
Group VII: Treatment sequence: T2-R-T3Experimental Treatment3 Interventions
Group VIII: Treatment sequence: T2-R-T1Experimental Treatment3 Interventions
Group IX: Treatment sequence: T1-T3-RExperimental Treatment3 Interventions
Group X: Treatment sequence: T1-T2-RExperimental Treatment3 Interventions
Treatments: T1: Lamotrigine T2: BI 409306 T3: BI 425809 R: Placebo
Group XI: Treatment sequence: T1-R-T3Experimental Treatment3 Interventions
Group XII: Treatment sequence: T1-R-T2Experimental Treatment3 Interventions
Group XIII: Treatment sequence: R-T3-T2Experimental Treatment3 Interventions
Group XIV: Treatment sequence: R-T3-T1Experimental Treatment3 Interventions
Group XV: Treatment sequence: R-T2-T3Experimental Treatment3 Interventions
Group XVI: Treatment sequence: R-T2-T1Experimental Treatment3 Interventions
Group XVII: Treatment sequence: R-T1-T3Experimental Treatment3 Interventions
Group XVIII: Treatment sequence: R-T1-T2Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamotrigine
2011
Completed Phase 4
~2490
BI 409306
2011
Completed Phase 2
~1020
Placebo
1995
Completed Phase 3
~2670
BI 425809
2019
Completed Phase 2
~630

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,867 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
2020. "A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04602221.
~9 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top