Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 425809

• Registration Number: NCT02362516
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-13
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 425809	BI 425809	-

Primary Outcome Measures

Name	Time	Method
AUC0-14 (area under the concentration-time curve of the analyte in plasma and CSF over the time interval from 0 to 14h)	17 days
Cmax (maximum measured concentration of the analyte in plasma and CSF)	17 days
C312 (concentration of the analyte in plasma and CSF at the time point 312h)	17 days

Secondary Outcome Measures

Name	Time	Method
frequency [N(%)] of subjects with drug-related adverse events (AEs)	30 days

Trial Locations

Locations (1)

1346.3.32001 Boehringer Ingelheim Investigational Site; 🇧🇪 Antwerpen, Belgium