A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food

NCT05347004 | Completed Phase 1 Results

• 2 other identifiers: 1346-00532021-006659-33
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without food (Reference treatment, R).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  This outcome measured the area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.

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

  This outcome measured the maximum measured concentration of BI 425809 in plasma (Cmax) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.

Secondary Outcomes (1)

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

  From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.

Study Arms (2)

BI 425809 without food (R), then BI 425809 with food (T)

EXPERIMENTAL

Drug: BI 425809

BI 425809 with food (T), then BI 425809 without food (R)

EXPERIMENTAL

Drug: BI 425809

Interventions

BI 425809 DRUG

BI 425809

Also known as: Iclepertin

BI 425809 with food (T), then BI 425809 without food (R); BI 425809 without food (R), then BI 425809 with food (T)

Eligibility Criteria

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

You may qualify if:

• Subjects will only be included in the trial if they meet the following criteria:
• Healthy male or female 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 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
• Either male subject, or female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
• Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
• Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
• Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Sexually abstinent
• A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
• Surgically sterilised (including hysterectomy)
• Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 Unites per liter (U/L) and estradiol below 30 nanogram per liter (ng/L) is confirmatory)

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 Publications (1)

• Madari S, Breithaupt-Groegler K, English BA, Hohl K, Jungnik A, Desch M. Assessing the Effect of Food on the Pharmacokinetics of Iclepertin in Healthy Volunteers: A Phase I, Open-Label, Randomised, Cross-over Trial. Eur J Drug Metab Pharmacokinet. 2025 Sep;50(5):399-408. doi: 10.1007/s13318-025-00956-1. Epub 2025 Jul 17.

  PMID: 40676451 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

BI 425809

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: October 25, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)