A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood

NCT05076409 | Completed Phase 1 Results

• 2 other identifiers: 1346-00172021-003389-10
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 215 h Post Administration of BI 425809 (AUC0-215)

  Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 h post administration of BI 425809 (AUC0-215) is reported.

  Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.

• Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

  Maximum measured concentration of BI 425809 in plasma (Cmax) is reported.

  Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.

Study Arms (1)

BI 425809 (R)/BI 425809 + fluconazole (T)

EXPERIMENTAL

Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R). In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)). There was a washout interval of at least 16 days between the administrations of BI 425809 in the 2 trial periods.

Drug: BI 425809; Drug: fluconazole

Interventions

BI 425809 DRUG

Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 1. Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 2.

Also known as: Iclepertin

BI 425809 (R)/BI 425809 + fluconazole (T)

fluconazole DRUG

Fluconazole orally as hard capsules once daily for 13 days (Day -4 up to Day 9) in period 2.

BI 425809 (R)/BI 425809 + fluconazole (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 (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 Kilograms/Square Meter (kg/m2) (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (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 millimetres 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
• Relevant 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

BI 425809; Fluconazole

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The objective of this trial was to evaluate the pharmacokinetics of BI 425809 under steady state conditions of fluconazole. BI 425809 was administered after the fifth of the 13 daily doses of fluconazole. The steady state analysis of fluconazole was assessed from the time of BI 425809 dosing up to 215 h thereafter in order to achieve the objective.

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: October 5, 2021
• First Posted: October 13, 2021
• Study Start: October 19, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)