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 (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)
Overview
- Phase
- Phase 1
- Intervention
- BI 425809
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- frequency [N(%)] of subjects with drug related adverse events (AEs)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 425809 very low dose - part I
Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days
Intervention: BI 425809
Placebo - part I
Part I only - placebo tablet, oral administration with 240ml water, over 14 days
Intervention: Placebo
BI 425809 low dose - part I
Part I - low dose tablet, oral administration with 240 ml water, over 14 days
Intervention: BI 425809
BI 425809 medium dose - part I
Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days
Intervention: BI 425809
BI 425809 high dose -part I
Part I only - high dose tablet, oral administration with 240 ml water, over 14 days
Intervention: BI 425809
BI 425809 low dose - part II
Part II - one low dose tablet on day 1 of visit 2 and 2a
Intervention: BI 425809
BI 425809 very high dose -part I
Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days
Intervention: BI 425809
Outcomes
Primary Outcomes
frequency [N(%)] of subjects with drug related adverse events (AEs)
Time Frame: 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
Time Frame: up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma) only part II
Time Frame: up to 96 hours
Secondary Outcomes
- 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)