Safety and Tolerability of BI 409306 in Patients With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: BI 409306; Drug: Placebo

• Registration Number: NCT01892384
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-04
• Primary Completion: 2013-12-05
• Study Completion: 2013-12-05
• Results First Submitted: 2023-08-10
• Results First Submitted QC: 2023-08-10
• Results First Posted: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 dose 1	BI 409306	low dose, once daily
Placebo	Placebo	placebo, once daily
BI 409306 dose 2	BI 409306	medium dose, once daily
BI 409306 dose 3	BI 409306	high dose, once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	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.
Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)	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.
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)	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.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Tmax)	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.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)	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.
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)	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.

Trial Locations

Locations (1)

1289.18.1 Boehringer Ingelheim Investigational Site; 🇺🇸 Austin, Texas, United States