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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05707403
Other study ID # 1305-0030
Secondary ID 2022-003119-27
Status Completed
Phase Phase 1
First received
Last updated
Start date February 14, 2023
Est. completion date March 28, 2023

Study information

Verified date April 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 28, 2023
Est. primary completion date March 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 65 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-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 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 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 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 (including but not limited to major depressive disorder or history of suicide attempts) - History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BI 1015550
Treatment T
BI 1015550 mixed with [C-14]-BI 1015550
Treatment R

Locations

Country Name City State
Netherlands ICON Groningen

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the concentration-time curve of [14C]-BI 1015550 in plasma after intravenous (i.v.) administration over the time interval from 0 to infinity (AUC0-8) up to 10 days
Primary Area under the concentration-time curve of BI 1015550 in plasma after oral (p.o.) administration over the time interval from 0 to infinity (AUC0-8) up to 8 days
Secondary Maximum measured concentration of BI 1015550 in plasma after oral (p.o.) administration (Cmax) up to 8 days
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