A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood

Healthy Clinical Trial

Official title:

Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05965583
• Other study ID #: 1485-0003
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: October 24, 2023

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• 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, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests

• Age of 18 to 55 years (inclusive)

• Body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) (inclusive)

• Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

• Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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

• Relevant chronic or acute infections

Further exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1815368
BI 1815368
• Itraconazole
Itraconazole

Locations

Country	Name	City	State
Germany	Humanpharmakologisches Zentrum Biberach	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		Up to day 7 after BI 1815368 administration
Primary	Maximum measured concentration of the analyte in plasma (Cmax)		Up to day 7 after BI 1815368 administration
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		Up to day 7 after BI 1815368 administration

External Links

•   Related Info