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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT03175211 (opens ClinicalTrials.gov in a new tab)Other id1404-0001Other id2017-000295-29Other id2017

Overview

Status
Completed
Phase
Phase 1
Enrollment
20 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Single masking
Countries
1 country

Germany

Start
30 Jun 2017
Primary completion
19 Feb 2018
Completion
19 Feb 2018
First posted
5 Jun 2017
Last update posted
16 Jul 2018
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1

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

    NCT03175211

    30 Jun 2017 to 19 Feb 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • BI 456906Drug
  • PlaceboDrug

Arms2

  • Experimental

    BI 456906

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Up to 672 hours

Secondary outcomes(2)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2023

12 results

Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906.

Jungnik et al. 2023Diabetes, obesity & metabolismcited by 55

PMID 36527386DOI 10.1111/dom.14948PUB-36527386

Full text at the publisher12 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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