A Study to Test How Different Doses of BI 1015550 Are Taken up in the Body of Healthy Japanese Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550

• Registration Number: NCT06139302
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2023-12-20
• Primary Completion: 2024-02-07
• Study Completion: 2024-02-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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), 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1015550 low dose	BI 1015550	-
BI 1015550 high dose	BI 1015550	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 7 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 7 days

Trial Locations

Locations (1)

SOUSEIKAI Sumida Hospital; 🇯🇵 Tokyo, Sumida-ku, Japan