Phase 1
Completed N=80
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Healthy
Source: ClinicalTrials.gov NCT01763333 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Subjects With Drug Related Adverse Events — 0.0; 33.3; 16.7; 16.7 Percentage of participants
Summary
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Drug Related Adverse Events |
0.0; 33.3; 16.7; 16.7; 25.0; 0.0 | — |
| SECONDARY Cmax |
117; 268; 623; 728; 1430; 112 | — |
| SECONDARY Tmax (Time From Dosing to Maximum Measured Concentration) |
1.74; 1.51; 1.75; 1.25; 2.23; 0.63 | — |
| SECONDARY AUC0-inf |
768; 1690; 3990; 4040; 8900; 428 | — |
| SECONDARY AUC0- tz |
741; 1670; 3950; 3990; 8830; 403 | — |
| SECONDARY t1/2 (Terminal Half-life of the Analyte in Plasma) |
10.80; 8.58; 12.10; 11.60; 12.00; 13.90 | — |
| SECONDARY f t1-t2 (SRD-Part) |
3.02; 2.75; 3.43; 1.95; 1.87; 3.97 | — |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01763333). 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.