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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05707403
Collaborator
(none)
8
Enrollment
1
Arm
1.2
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Drug: BI 1015550
  • Drug: BI 1015550 mixed with [C-14]-BI 1015550
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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
Anticipated Study Start Date :
Feb 14, 2023
Anticipated Primary Completion Date :
Mar 23, 2023
Anticipated Study Completion Date :
Mar 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test treatment (T) followed by Reference treatment (R)

Drug: BI 1015550
Treatment T

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

Outcome Measures

Primary Outcome Measures

  1. 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-∞) [up to 10 days]

  2. 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-∞) [up to 8 days]

Secondary Outcome Measures

  1. Maximum measured concentration of BI 1015550 in plasma after oral (p.o.) administration (Cmax) [up to 8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05707403
Other Study ID Numbers:
  • 1305-0030
  • 2022-003119-27
First Posted:
Jan 31, 2023
Last Update Posted:
Feb 7, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 7, 2023