A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet

Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 425809 Administered as an Oral Dose With an Intravenous Microtracer Dose of [C-14]-BI 425809 in Healthy Male Volunteers

The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as intravenous microtracer (Reference, R).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 425809; Drug: [C-14]-BI 425809

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male subjects according to the assessment of the investigator, 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 65 years (incl.)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

• Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:

  • Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
  • Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
  • Condoms plus surgically sterilised partner (including hysterectomy) or
  • Condoms plus intrauterine device or
  • Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner to the study drug via seminal fluid.
  • Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.

Exclusion Criteria:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Clinically significant gastrointestinal, hepatic, renal, respiratory (including but not limited to interstitial lung disease), cardiovascular, metabolic, immunological or hormonal disorders
• Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BI 425809 (T) BI 425809 mixed with [C-14]-BI 425809 (R); All healthy participants received one unlabelled oral dose of 25 milligram (mg) BI 425809 in the film coated tablet (Test treatment, T) and in addition an intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (14-C) (Reference treatment, R), consisting of 27 μg unlabelled BI 425809 mixed with 3 μg labelled [C-14]-BI 425809 in 10 milliliter (mL) iv solution at a concentration of 3 μg BI 425809 (C-14)/ mL. Both treatments were given in the fasted state on the same study day. The reference treatment started 4 hour (h) after administration of the test treatment.

Drug: BI 425809; One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours.; Other Names: Iclepertin; Drug: [C-14]-BI 425809; Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T.; Other Names: Iclepertin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time Interval From 0 to Infinity (AUC0-∞, Norm)	The dose-normalised area under the concentration-time curve of the analyte ([14C]-BI 425809 after iv administration as well as for BI 425809 after oral administration) over the time interval from 0 to infinity (AUC0-∞, norm) is presented. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model performed on the logarithmic scale, including 'formulation' as a fixed effect and 'subject' as a random effect. For treatment T, pharmacokinetic samples were collected within 2 h prior to the drug administration and at 1, 2, 3, 4.083, 6, 8, 12, 24, 72, 120 and at 168 h after single oral administration of unlabelled BI 425809. For treatment R, samples were collected at 3, 4.083, 4.167, 4.25, 4.5, 5, 6, 7, 8, 12, 16, 24, 72, 120 and 168 h after single oral administration of unlabelled BI 425809.	Pharmacokinetic samples were collected within 2 h before and up to 168 h after single oral administration of unlabelled BI 425809. Further details are in description.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of the BI 425809 in Plasma After a Single Oral Dose (Cmax)	Cmax, maximum measured concentration of the BI 425809 in plasma after a single oral dose is presented.	Pharmacokinetic samples were collected within 2:00 h:m prior to the drug administration and at 1:00, 2:00, 3:00, 4:05, 6:00, 8:00, 12:00, 24:00, 72:00, 120:00 and at 168:00 h:m after drug administration.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS. The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males. Clin Drug Investig. 2022 Jan;42(1):87-99. doi: 10.1007/s40261-021-01111-9. Epub 2021 Dec 22.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents; BI 425809
• Other Study ID Numbers: 1346-0015; 2018-001194-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No