Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02044406

Enrollment

Registered

2014-01-24

Start date

2014-01-31

Completion date

2014-09-30

Last updated

2014-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

Interventions

DRUGBI 1181181

single dose (low to high dose)

DRUGBI 1181181, R

powder for oral solution

DRUGBI 1181181, T2

tablet, fasted

DRUGPlacebo to BI 1181181

Placebo to BI 1181181

DRUGBI 1181181, T1

tablet, fed

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests * Age 18 to 50 years (incl.) * Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator * Repeated measurement of systolic blood pressure \< 90 mmHg and \>= 140 mmHg at screening * Repeated measurement of diastolic blood pressure \< 55 and \>= 90 mmHg at screening * Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Design outcomes

Primary

Measure	Time frame
Number (%) of subjects with drug-related adverse events (AEs)	up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h

Secondary

Measure	Time frame
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72 h
Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)	up to 72 h
t1/2 (terminal half-life of the analyte in plasma)	up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)	up to 72 h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026