Phase 1
Completed N=24
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
Healthy
Source: ClinicalTrials.gov NCT01835899 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events — 16.7; 44.4; 11.1 Percentage of participants
Summary
To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events |
16.7; 44.4; 11.1 | — |
| SECONDARY Cmax |
24.0; 133.0 | — |
| SECONDARY AUCt,1 |
94.9; 622 | — |
| SECONDARY AUC0-infinity |
131; 958 | — |
| SECONDARY Cmax,ss |
28.6; 199 | — |
| SECONDARY AUCt,ss |
148; 1090 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
- Subjects unable to understand or to comply with study requirements
Data sourced from ClinicalTrials.gov (NCT01835899). 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. Informational only — not medical advice.