Phase 1
Completed N=48
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT01681277 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Drug-related Adverse Events — 33.3; 33.3; 22.2; 88.9 percentage of participants
Summary
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Drug-related Adverse Events |
33.3; 33.3; 22.2; 88.9; 77.8 | — |
| PRIMARY Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings |
0; 0; 0; 0; 0 | — |
| SECONDARY Cmax,ss |
119; 261; 648; 549 | — |
| SECONDARY Tmax,ss |
0.500; 0.500; 0.750; 0.750 | — |
| SECONDARY AUCtau,ss |
491; 1290; 3030; 2290 | — |
| SECONDARY t1/2,ss |
14.0; 12.9; 12.9; 13.1 | — |
| SECONDARY RA,Cmax |
1.36; 1.15; 1.09; 0.915 | — |
| SECONDARY RA,AUC |
1.29; 1.48; 1.37; 1.05 | — |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01681277). 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.