Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers

Phase 1

Completed

• Conditions: Schizophrenia; Alzheimer Disease
• 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

• Registration Number: NCT02392468
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-19
• Study Start: 2015-04-15
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-10
• Results First Submitted: 2023-08-10
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Results First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 409306 25 milligram (mg) - Alzheimer patients	BI 409306 25 mg	Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 100 mg - Alzheimer patients	Placebo matching BI 409306 25 mg	Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
BI 409306 100 mg - Alzheimer patients	BI 409306 50 mg	Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
BI 409306 25 mg - Schizophrenia patients	Placebo matching BI 409306 50 mg	Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 25 milligram (mg) - Alzheimer patients	Placebo matching BI 409306 50 mg	Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 25 mg - Schizophrenia patients	BI 409306 25 mg	Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 100 mg - Schizophrenia patients	Placebo matching BI 409306 25 mg	Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
BI 409306 100 mg - Schizophrenia patients	BI 409306 50 mg	Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
BI 409306 25 mg - Healthy volunteers	Placebo matching BI 409306 50 mg	Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 25 mg - Healthy volunteers	BI 409306 25 mg	Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
BI 409306 100 mg - Healthy volunteers	Placebo matching BI 409306 25 mg	Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
BI 409306 100 mg - Healthy volunteers	BI 409306 50 mg	Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial	From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)	Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.	Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is reported.
The Percentage of Participants With Drug-related AEs as Determined by the Investigator at EOT	From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.	The percentage of participants with drug-related adverse events (AEs) as determined by the investigator at end of trial (EOT) is reported.; Percentages were rounded to one decimal place.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)	Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.	Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is reported.

Trial Locations

Locations (3)

Memory Enhancement Center of America, Inc.; 🇺🇸 Eatontown, New Jersey, United States

Community Clinical Research, Inc.; 🇺🇸 Austin, Texas, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States