Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 425809

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • 1346.3.32001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 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

Exclusion criteria:

• Any finding in the medical examination (including blood pressure (BP), puls 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 and considered as clinical relevant by investigator
• 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
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 425809 5 mg; Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.	Drug: BI 425809; Tablet; Other Names: Iclepertin
Experimental: BI 425809 10 mg; Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.	Drug: BI 425809; Tablet; Other Names: Iclepertin
Experimental: BI 425809 25 mg; Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.	Drug: BI 425809; Tablet; Other Names: Iclepertin
Experimental: BI 425809 50 mg; Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.	Drug: BI 425809; Tablet; Other Names: Iclepertin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)	Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).	0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)	Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).	1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Maximum Measured Concentration of BI 425809 in CSF (Cmax)	Maximum measured concentration of BI 425809 in CSF is reported.	1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)	Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.	0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in CSF at the Time Point 312h (C312)	Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.	1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)	Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.	10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Drug-related Adverse Events (AEs)	Percentage of participants with drug-related adverse events (AEs).	From the first drug administration until 11 days after the last drug administration, up to 30days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2015
• Primary Completion (Actual): June 19, 2015
• Study Completion (Actual): June 19, 2015

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimated): February 13, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents; BI 425809
• Other Study ID Numbers: 1346.3; 2014-005652-26 (EudraCT Number: EudraCT)

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