A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood
Launched by BOEHRINGER INGELHEIM · May 14, 2024
Trial Information
Current as of February 18, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 1. 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
- • 2. Age of 18 to 55 years (inclusive)
- • 3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- • 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Exclusion Criteria:
- • 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- • 2. 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
- • 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- • 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- • 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- • 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- • 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- • 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Biberach, , Germany
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0