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Completed

NCT Number: NCT06419660

A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood

The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 3000202 in plasma.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ICH-GCP and local legislation prior to admission to the trial

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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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.

Treatment and study plan

BI 300202

Drug

BI 300202

Esomeprazole

Drug

esomeprazole

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 4 days

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

    Time frame: Up to 4 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 4 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose BI 3000202 in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 17, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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