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NCT02392468 · ClinicalTrials.gov registry record · Phase 1
Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT02392468: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT02392468 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02392468, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
Primary Outcome
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported. Percentages were rounded to one decimal place.
Interventions
- DRUG Placebo matching BI 409306 25 mg
- DRUG Placebo matching BI 409306 50 mg
- DRUG BI 409306 25 mg
- DRUG BI 409306 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-04-15 |
| Est. Completion | 2017-08-10 |
| Phase | Phase 1 |
What the finished NCT02392468 record still lists
NCT02392468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo matching BI 409306 25 mg is the first listed.
NCT02392468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02392468 about?
NCT02392468 is a clinical study titled "Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers". Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
What is the current status of trial NCT02392468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-04-15. Estimated completion is 2017-08-10.
What interventions are being tested in trial NCT02392468?
The interventions under investigation include: Placebo matching BI 409306 25 mg (DRUG), Placebo matching BI 409306 50 mg (DRUG), BI 409306 25 mg (DRUG), BI 409306 50 mg (DRUG).
Who is sponsoring clinical trial NCT02392468?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02392468's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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