A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1815368 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857878
• Other study ID #: 1485-0002
• Secondary ID: 2023-503815-13-0
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to investigate safety, tolerability, and pharmacokinetics following multiple rising doses of BI 1815368 in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 6, 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 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 55 years (inclusive).

• Body mass index (BMI) of 19 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 50 to 90 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1815368
BI 1815368
• Matching placebo
Matching placebo

Locations

Country	Name	City	State
Belgium	SGS Life Science Services - Clinical Research	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator		Up to 29 days
Secondary	Area under the concentration-time curve of BI 1815368 in plasma at steady state over a uniform dosing interval t (AUCt,ss)		Up to 16 days
Secondary	Minimum concentration of BI 1815368 in plasma at steady state over a uniform dosing interval t (Cmin,ss)		Up to 16 days
Secondary	Maximum measured concentration of BI 1815368 in plasma at steady state over a uniform dosing interval t (Cmax,ss)		Up to 16 days

External Links

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