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CompletedNCT03175211Updated Jul 16, 2018

Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

A Phase 1 interventional study of BI 456906 and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    BI 456906

    Drug: BI 456906

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBI 456906

    single dose

  • DrugPlacebo

    single dose

06

What researchers measure

Primary outcomes

  1. [N (%)] of subjects with drug-related adverse events.

    Time frame: Up to 672 hours

Secondary outcomes

  1. 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

  2. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 672 hours

07

Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03175211
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 5, 2017
Start date
Jun 30, 2017
Primary completion
Feb 19, 2018
Completion
Feb 19, 2018
Last update
Jul 16, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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