Phase 1
Completed N=80
First in Man Trial of BI 113608
Healthy
Source: ClinicalTrials.gov NCT01540825 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jan 2017
Primary outcomePrimary: Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test — 0; 0; 0; 0 Percentage of participants
Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.
A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Drug-related Adverse Events |
0.0; 33.3; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Assessment of Tolerability by the Investigator |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Cmax |
1.36; 1.66; 2.83; 7.33; 23.5; 52.6 | — |
| SECONDARY Tmax |
0.63; 0.88; 2.25; 1.75; 1.00; 1.10 | — |
| SECONDARY AUC0-tz |
6.15; 11.4; 19.1; 53.9; 142; 304 | — |
| SECONDARY AUC0-infinity |
6.54; 12.2; 19.9; 55.2; 144; 307 | — |
| SECONDARY t1/2 |
4.66; 8.10; 8.56; 8.08; 10.3; 9.51 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01540825). 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.