Phase 1
N=40
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01611311 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Percentage of Subjects With Investigator Defined Drug-Related Adverse Events — 50.0; 50.0; 66.7; 50.0 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 409306 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Investigator Defined Drug-Related Adverse Events |
50.0; 50.0; 66.7; 50.0; 55.6; 44.4 | — |
| PRIMARY Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) |
679; 1310; 459; 768 | — |
| SECONDARY Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) |
694; 1740; 516; 872 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) |
1570; 2690; 622; 1030 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) |
1800; 3410; 682; 1250 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) |
0.625; 0.750; 0.500; 0.500 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) |
0.634; 0.417; 0.333; 0.367 | — |
Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.
Eligibility Criteria
Inclusion criteria
- Healthy male/female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01611311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.