Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 425809; Drug: Placebo

• Registration Number: NCT02337283
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-13
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 very low dose - part I	BI 425809	Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days
Placebo - part I	Placebo	Part I only - placebo tablet, oral administration with 240ml water, over 14 days
BI 425809 low dose - part I	BI 425809	Part I - low dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 medium dose - part I	BI 425809	Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 high dose -part I	BI 425809	Part I only - high dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 low dose - part II	BI 425809	Part II - one low dose tablet on day 1 of visit 2 and 2a
BI 425809 very high dose -part I	BI 425809	Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days

Primary Outcome Measures

Name	Time	Method
frequency [N(%)] of subjects with drug related adverse events (AEs)	up to 25 days after first drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) only part II	up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma) only part II	up to 96 hours

Secondary Outcome Measures

Name	Time	Method
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)	up to 216 hours after last dose
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)	up to 216 hours after last dose
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) only part II	up to 96 hours
AUCt 0-24(area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)	up to 72 hours after first dose
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 hours after first dose

Trial Locations

Locations (1)

1346.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany