Phase 1
Completed N=62
Safety Tolerability and Pharmacokinetic of BI 411034
Healthy
Source: ClinicalTrials.gov NCT01581684 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants With Drug Related AEs — 1; 0; 0; 1 participants
Summary
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).
Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Drug Related AEs |
1; 0; 0; 1; 1; 1 | — |
| PRIMARY Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Measured Concentration (Cmax ) |
61.7; 236; 566; 629; 2630; 4610 | — |
| SECONDARY Time to Maximum Measured Concentration (Tmax) |
0.5; 0.63; 0.63; 1.00; 0.62; 0.62 | — |
| SECONDARY Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) |
134; 729; 1410; 1900; 6140; 13300 | — |
| SECONDARY Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) |
77.6; 290; 530; 860; 2070; 3390 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01581684). 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.