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

NCT05965583 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1485-00032023-503783-16-00
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.

  Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

• Maximum Measured Concentration of BI 1815368 in Plasma (Cmax)

  Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.

  Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

Study Arms (1)

BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

EXPERIMENTAL

Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days.

Drug: BI 1815368; Drug: Itraconazole

Interventions

BI 1815368 DRUG

BI 1815368

BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

Itraconazole DRUG

Itraconazole

Also known as: Sempera®

BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: August 2, 2023
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)