A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood

NCT06041438 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1484-00032023-503542-31-00
• 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 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

  Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

• Maximum Measured Concentration of BI 1584862 in Plasma (Cmax)

  Maximum measured concentration of BI 1584862 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

  Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

Study Arms (1)

BI 1584862 (R), then BI 1584862 + itraconazole (T)

EXPERIMENTAL

Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period.

Drug: BI 1584862; Drug: Itraconazole

Interventions

BI 1584862 DRUG

One dose with 240 mL of water after an overnight fast of at least 10 h

BI 1584862 (R), then BI 1584862 + itraconazole (T)

Itraconazole DRUG

200 mg daily after an overnight fast of at least 9 h for several consecutive days

BI 1584862 (R), then BI 1584862 + itraconazole (T)

Eligibility Criteria

• Age: 18 Years - 50 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 (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

You may not qualify if:

• 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 18, 2023
• Study Start: September 29, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: June 3, 2026
• Results First Posted: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)