A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

NCT05723874 | Completed Phase 1 Results

• 2 other identifiers: 1346-00562021-006676-17
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

  Area under the concentration-time curve of BI 425809 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is reported. The dosing interval τ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1.

  Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

• Maximum Measured Concentration of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

  Maximum measured concentration of BI 425809 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is reported. The dosing interval τ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1.

  Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

Secondary Outcomes (1)

• Minimum Concentration of BI 425809 in Plasma at Steady State Within a Uniform Dosing Interval τ (Cmin,ss)

  Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

Study Arms (1)

BI 425809 (reference treatment, R) then BI 425809 + bosentan (test treatment, T)

EXPERIMENTAL

Reference treatment (R): healthy male subjects administered orally once daily one film-coated tablet of 10 milligram (mg) of BI 425809 with 240 milliliter (mL) of water for 10 days (day 1 - day 10). Test treatment (T): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 14 days (day 1 - day 14). In addition, subjects administered orally twice daily one film-coated tablet of 125 mg of bosentan with 240 mL of water for 14 days (day 1- day 14). Between the two periods, there was no wash-out period. Period 2 (T) immediately followed Period 1 (R).

Drug: BI 425809; Drug: Bosentan

Interventions

BI 425809 DRUG

One daily film-coated tablet of 10 mg with 240 mL of water for 10 days (R) and for 14 days (T).

Also known as: Iclepertin

BI 425809 (reference treatment, R) then BI 425809 + bosentan (test treatment, T)

Bosentan DRUG

Two daily film-coated tablets of 125 mg with 240 mL of water for 14 days (T).

Also known as: Tracleer®

BI 425809 (reference treatment, R) then BI 425809 + bosentan (test treatment, T)

Eligibility Criteria

• Age: 30 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 30 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 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

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 millimetre of mercury (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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 425809; Bosentan

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 13, 2023
• Study Start: March 6, 2023
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)