Status:
COMPLETED
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.
Eligibility Criteria
Inclusion
- 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), Respiratory rate (RR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion
- Any finding in the medical examination (including BP, PR, RR 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(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 beats per minute (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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06139302
Start Date
December 20 2023
End Date
February 13 2024
Last Update
December 1 2025
Active Locations (1)
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1
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, Japan, 130-0004