DRUG
BI 456906
single dose
Status
Completed
Phase
Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
1
Study summary
The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing
Interventions
DRUG
single dose
DRUG
single dose
Timeline
First posted
Jun 5, 2017
Study start
Jun 30, 2017
Primary completion
Feb 19, 2018
Study completion
Feb 19, 2018
Results posted
Not reported
Registry updated
Jul 16, 2018
Outcomes
[N (%)] of subjects with drug-related adverse events.
Time frame · Up to 672 hours
AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)
Time frame · up to 168 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame · up to 672 hours
Eligibility
Inclusion criteria * Healthy male according to the assessment of the Investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 45 years (incl.) * Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria * Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation) * Further exclusion criteria apply
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Related trials
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Recruiting
80
2026-07
Boehringer Ingelheim · Obesity
Phase 3
Completed
5,531
2026-07
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
29
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis
Phase 3
Recruiting
1,800
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis
Phase 3
Recruiting
1,590
2026-07
Boehringer Ingelheim · Obesity · Diabetes Mellitus, Type 2
Phase 3
Completed
755
2026-06
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Completed
56
2026-06
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
64
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.