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CompletedNCT05467475Updated Jan 26, 2023

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood

A Phase 1 interventional study of BI 1819479 and Esomeprazole in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.

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

From the registry’s dates

  • Primary completion was Jan 2023, 3 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 1819479 in plasma.

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 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male subjects according to the assessment of the investigator, as 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 55 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Exclusion criteria

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minutes (bpm)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    esomeprazole + BI 1819479 (Test (T))/ BI 1819479 (Reference (R))

    Drug: BI 1819479 · Drug: Esomeprazole

  • Experimental
    BI 1819479 (R)/ esomeprazole + BI 1819479 (T)

    Drug: BI 1819479 · Drug: Esomeprazole

Interventions

  • DrugBI 1819479

    BI 1819479

  • DrugEsomeprazole

    Esomeprazole

    Also known as: Nexium®

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: Up to 31 days.

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

    Time frame: Up to 31 days.

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to 31 days.

07

Study locations

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

References and documents

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05467475
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 20, 2022
Start date
Oct 18, 2022
Primary completion
Jan 23, 2023
Completion
Jan 23, 2023
Last update
Jan 26, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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