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NCT05707403 | Completed | Healthy

A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
Sponsor:

Boehringer Ingelheim

Brief 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.

Condition or disease

Healthy

Intervention/treatment

BI 1015550

BI 1015550 mixed with [C-14]-BI 1015550

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 8 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1015550 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1015550 in Healthy Male Volunteers
Actual Study Start Date : February 14, 2023
Estimated Primary Completion Date : March 28, 2023
Estimated Study Completion Date : March 28, 2023
Arm Intervention/treatment

Experimental: Test treatment (T) followed by Reference treatment (R)

Comrade: BI 1015550

Drug: BI 1015550 mixed with [C-14]-BI 1015550
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body

Location Details

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A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Netherlands,

ICON

Groningen, Netherlands, 9728 NZ