Phase 1
N=80
First in Man Trial of BI 113608
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01540825 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jan 2017
Primary outcome: 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 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 113608 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2012
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 | — |
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.
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.